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starrsed auto compact instructions for use

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1. 03 02 2012 1 09 02 2012 03 02 2012 16 01 2012 03jo2 2012 11 01 2012 07 30 5 03 02 2012 10 01 2012 07 30 5 03 02 2012 09 01 2012 07 30 5 03 02 2012 06 01 2012 07 19 5 03 02 2012 05 01 2012 07 19 5 03 02 2012 04 01 2012 07 19 5 03 02 2012 03 01 2012 08 19 5 03 02 2012 02 01 2012 08 19 5 03 02 2012 E sei 03 02 2012 13 01 2012 07 35 5 03 02 2012 12 01 2012 07 30 5 03 02 2012 12 01 2012 07 30 5 03 02 2012 GC 5CH 5 T545 5 5 Brot S H 5 S H 5 Site TSGFS5 SCH S Si 15 5 5e 5 5e 5 SE 5 H 5 56 5 KS la Is IE IE s s s ee IST ES ESESTTSESTTSESTSESESESESESSTSESTSIESTESTES aT G ET Uncorrected QC resuk is c zj H Display Results table Results are shown in table as default QC sample ID Read from the barcode The original StaRRsed Control barcode batch number Linked lab ID The Lab ID is given if it is linked to the StaRRsed Control sample ID Sampling date The date and time when the QC sample was aspirated Expiry date If the StaRRsed Control expiry date is exceeded it is not possible to continue with this QC sample The sample is not measured but the failed attempt is logged in the table Page 32 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Auto Compact program Expected ESR This is the temperature corrected mean value
2. Pipette in which the sample was measured Shows any ESR error code e g Too many borders found StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN RR mechatronics Auto Compact program 5 3 3 Display rack history C i Sample Jj History ke Reagents Maintenance Settings m Service J Sample ID TEST 00172 1612714243 4293810 4293502 4293810 4293825 4293810 13 29 17 13 25 19 13 20 09 13 16 31 22 Sep 11 22 Sep 11 22 Sep 11 Sep 11 BD Display rack details oer end gro HOST Last rack 2 Last rack 3 After completion of the rack the status of the rack is displayed here The last 10 racks are stored and can be selected The selected rack is displayed left above the selection window The previous 4 racks are also displayed and can be checked simultaneously More detailed information of the selected rack is shown with DISPLAY RACK DETAILS on page 30 ON The combinations of the pictograms have the following meaning II miam Barcode could not be read read failure 0000000944 Wu OK Barcode was read correctly but ESR is not required for this M sample 0000000941 meg ESR is required and waiting to be done 0000000940 m ois Ke ESR was measured successfully 0000000936 imm os 19 ESR was measured but with fill errors The Clear rack history button will clear the contents of the rack history file and restart to build up a new
3. 31007002 31 00200210 25 34 S 25 e EDTA 150 31007502 31 01 2012 09 47 53 114 24 en EDTA 1607 31010802 suouzo1209 52 44 s9 a 60 EDTA jl 170 IE EAD IHI a JU CLE SUN La A sendattonost 31013502 suouzo1210 26 122 e a e EDTA II saaros 100 31014002 sifoi201209 36 28 92 24 60 EDTA 190 31017502 3170142012 13 18 26 es e e EDTA ji xi Send patient result to HOST 2007 Display Full patient result EI In History the following options can be selected e DISPLAY PIPETTE DATA on page 25 Use button PRINT to send the selected data to the printer e DISPLAY SAMPLE HISTORY on page 26 e DISPLAY FULL PATIENT RESULT on page 27 In Display sample history are the following options available PRINT Send the selected result to the printer PRINT RESULT HEADER Only if option Settings General settings PRINT AFTER MEASUREMENT is switched ON it is possible to print a result header SEND ALL TO HOST Send all results again to the HOST SEND PATIENT RESULT TO HOST Send only the selected patient result to the HOST e DISPLAY RACK HISTORY on page 29 e DISPLAY RACK DETAILS on page 30 ANALYSE RESULTS on page 41 e ESR STATISTICS on page 31 e QCRESULTS on page 32 with StaRRsed Control e LINKED QC ID s on page 40 Page 24 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN E mechatronics 5 3 1 Display pipette data tory Auto Compact prog
4. same for all reagents 5 4 2 1 New reagent input cont aa New Reagent Information BN apen app RINSE SOLUTION 2500 ml Spoelviceistof Sp ll sung Solution de ringage Soluzione di lavaggio Soluci n de lavado Solu o rinse RR mechatronics Rinse solution solution New reagent information Lot number Lot number D Expire date Expire date Placed Month Year Jg SES Placed d 06 Oct 11 ez To save new information click OK x Back OK Cancel Data can be entered with the keyboard or with a barcode reader 1 First enter read the Article number 2 Enter read Lot number 3 Enter read the Expiry date if barcode reader is used cursor has to be in one of the two boxes 4 If necessary adjust the date when the reagent was placed 5 Check if the preview box shows the correct information then press OK StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Page 49 m mechatronics Auto Compact program 5 5 Maintenance screen H History 1d Reagents Maintenance Settings m Service E E When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE This screen has 5 sub screens PRIME ON PAGE 51 CLEAN CHECK SENSORS on page 54 DISPLAY ERROR HISTORY on page 56 DISPLAY MAINTENANCE HIST on page 57 MAINTENANCE INFO on page 58 SS cs Page 50 StaRRsed Auto Compact Instructions For Use
5. dilution errors or bubbles on top warnings see ESR Statistics screens on page 31 In case of a considerable number of pipettes with air bubbles e Perform the necessary maintenance or contact the service representative StaRRsed Auto Compact Instructions For Use Page 69 Version 1 07 MRN 074 EN mechatronics Operation 7 4 Turn off It is recommended to turn the StaRRsed Auto Compact off at the end of the day Before the instrument is turned off it is good practice to carry out the Daily maintenance on page 88 or at least the End of day wash procedure This will help to keep the instrument clean and almost free of bacterial growth for a period of days WARNING Always be aware of the dangers of infection especially during maintenance Take the appropriate precautions Note The StaRRsed Auto Compact may remain switched ON continuously However the customer should consider environmental issues such as energy consumption when the instrument is not to be used for some time It is also recommended to completely restart the instrument and if applicable Windows once in a while to clear the memory and ensure a stable operating system 7 4 1 End of day wash procedure Select the tab MAINTENANCE and press the button End of day wash A pop up screen is shown Selecting Close program will stop the program immediately without running the End of day wash procedure When End of day wash procedure is selected a selection screen fo
6. eseseseeseeeeeee 42 StaRRsed Auto Compact Instructions For Use Page 5 Version 1 07 MRN 074 EN mechatronics Contents 5 3 8 History aspect C T 43 5 3 9 History analyse error unde etre etree ee oe re eee ene eee eres 43 5 3 10 History analyse warning ccictieeisiwesisietesunetianiaeeiaberenbiareidteleberaieiixaeuanldecureeee 44 5 3 11 History sample analyse option day EEN 45 5 3 12 History sample analyse option 45 5 3 13 Set C NE CURT oo mE 46 5 3 14 Set end CONG E o EUNT 46 5 4 Reagents SCION iioii tities Oia oun a eerie aati 47 5 4 1 Display reagent history EE 48 5 4 2 New reagent iNput sceau icio ite repu Eege iesu dp ima 49 5 4 2 1 New reagent input cont EEN 49 5 5 Maintenance screen Lund desea oat id oda oai ua ind icd abismo d eset 50 5 5 1 Prime Clean t c S 51 5 5 1 1 Prime Rinse solution EEN 51 5 5 1 2 Prime Saline udin diee Eege 51 5 5 1 3 e UR UU m 52 5 5 1 4 Prime de ionized E 52 5 5 1 5 Qu uuN ncm 52 E a E E Girl E Un 52 5 5 1 7 Wash each pipette E 52 5 5 1 8 Wash only sample pipettes EEN 52 5 5 1 9 Wash all pipettes iiiieem ern eee inen niin 52 5 5 1 10 Fill and clean screen fs acacsienss tienienice nutans 53 5 5 1 11 End of day wash pDrorcedure ENNEN 53 5 5 2 CHEEK SENSOMS eegene EEA ENEE ETEA EEEE EAEE EETA 54 5 5 3 Display error history suos ciclo odd eds eii dia o pe ipei Sq e codi ducis qa asd iau ipM M
7. Replacing 1 Replace the top section A little silicon grease on the rim of separator will make the assembling and adjustment easier 2 lf applicable replace the bacterial HEPA filter For Maintenance Level 4 exhange bacterial HEPA filter QWLV040002 3 Re connect the silicon tube to the bottom tube connector 4 Liftleft cover 5 Lift stainless steel vacuum tube up 6 Insert the liquid separator sliding it over the support shelf 7 Pushthe liquid separator towards the rear with the sensor connectors in the holes 8 Release the stainless steel vacuum tube 9 Replace the waste container 10 Close left cover StaRRsed Auto Compact Instructions For Use Page 108 Version 1 07 MRN 074 EN mechatronics Work instruction StaRRsed Auto Compact Re mechatronics Work instruction Number 178 Page 1 of 1 Purpose Hazy problems Safety Bio Hazard area Instrument StaRRsed Auto Compact Revision 002 December 2013 Prepare disinfectant Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution Cleaning the diluent system Step 1 Bor 5 Remove the suction tube from the diluent bottle Place the suction tube in chlorine solution Use the PRIME DILUENT function This fills the dispenser system with the disinfectant After the prime sequence stops press PRIME DILUENT 5 times to fill the dispenser system with the disinfectant Leave the disinfe
8. e Check limit settings Screen messages Extra information SS QC icon is blinking at Sample The last QC sample was not e Press on QC icon screen within acceptable range or has e Press Accept to no result continue sampling without performing a new QC continuing could produce incorrect results Press Cancel to return Try new QC sample tube normal samples will be finished QC result out of range e Perform a new QC sample normal samples will be finished e If this error persists check clean instrument QC sample expired e Use anew batch of Starrsed Control It is not possible to link this Lab The Linked QC ID s table may Consider changing ID Lab ID is already linked only contain one link to a AUTOMATICALLY REMOVE LINKED QC particular Lab ID ID AFTER RESULT option to YES Last QC result was out of Result of last QC sample was The last QC result should be range Continuing could not within acceptable range evaluated by authorized staff produce incorrect results Do to decide whether the you still want to continue StaRRsed Auto Compact may run patient samples depending on the the nature of errors e Press Yes to continue sampling without performing a new QC press No to return and take appropriate action General errors Extra information COMME Barcode is not accepted Barcode cannot be read e Check barcode Data is incorrect Page 86 StaRRsed Auto Compact Instructions For Use Version 1 07
9. in degrees Centigrade 10 Error message if the Analyser detects an error 11 EDTA mode POM el oe REPORT EXAMPLE Not to scale StaRRsed Date 20 05 14 Time 15 28 1 2 3 4 5 6 7 8 9 10 11 915001 42 84 75 CLEAR 17 30 23 EDTA StaHRsed Auto Compact Instructions For Use Page 63 Version 1 07 MRN 074 EN mechatronics Reporting 6 2 3 ESR Error Error messages can be found on the printout in column 10 If errors are found during the measurement the Compact will give an audible alarm The Error message is displayed on the main screen 6 2 3 1 ESR Error and Warning code messages ESR ERROR and WARNING code messages This code appears in the sample data record at column 10 The following codes are defined O0 No errors 1 No cells plasma found Error No contents could be detected in the pipette ESR Probably gt 140 mm Error Extremely high ESR value Too many borders found Error More than three borders found possibly air bubbles See Section Trouble shooting Air bubbles on page 82 4 Column height lt nnn gt Warning Column height must be between 180 and 210mm lt nnn gt the actual column height 5 Measure error Warning The down count is not equal to the up count from the measure head 6 Bubbles on top Warning Air bubbles on top of the ESR See Section Trouble shooting Air bubbles on page 82 7 Limit error Error One of the following limits are out
10. servicing and repair of the instrument in detail Contains detailed descriptions of parts assembly drawings modifications extended trouble shooting flow diagrams etc Only available in English Installation Manual IM Intended for trained service engineers Contains instructions and procedures for installation and start up Only available in English Manuals are available in PDF and HTML format and can be downloaded from http www rrmechatronics com Page 10 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Rm 7 mechatronics Instrument description 2 INSTRUMENT DESCRIPTION The StaRRsed Auto Compact can accommodate sample racks from different manufacturers The individual rack with the blood samples is snapped into the Mechatronics rack adapter and need only be placed on the entry platform of the StaRRsed Rack unit The operator simply presses the button Sample mode and walks away The instrument picks up the rack and mixes the blood by rotating the rack 8 times as recommended by the ICSH Barcode labels are read and if an ESR has been requested blood is aspirated from the sample tube Thereafter the Rack is rotated one time to ensure each blood sample is thoroughly mixed and the sample is picked up to be aspirated Aspiration takes place via Mechatronics proprietary double needle mechanism The citrate dilution takes place in a 4 1 ratio and is achieved with 3 accuracy Eighty four Westergren pipet
11. 09 0B Dec 08 13 48 45 05 Dec 06 10 35 05 05 Dec 08 12 49 32 03 Dec 08 11 46 17 0 amp Dec 08 08 21 42 02 Dec 08 13 02 20 01 Dec 08 12 07 46 01 0608 14 23 14 22r 1316 29 sje gla assa zssssszs ng ETag EDTAT10 EDTAILO TEDTAMO ETag Trovit Too many borders found The dilution error detection is a user setting and can be changed in SETTINGS dilution error detection to 0 25 In this example the dilution error detection is set to 10 and limit errors set to YES By selecting Dilution gt 110 all the samples with a dilution rate gt 110 are displayed in the table By selecting Dilution lt 90 all the samples with a dilution rate lt 90 are displayed in the table In the header of the table the names of the columns are shown Double click the header of any column to sort the table by this column in ascending order Page 42 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Rm mechetronics Auto Compact program 5 3 8 History aspect Analyse results m pA Se ee Dome Ss TI om p 4 menu 02 Dec 09 16 16 20 j I Se 03 Dec 08 12 53 49 Iu 02 0ec 08 10 47 03 EE 3046802 29Dec0813 2923 4 var ium Hazy lt 10 DTA I ASPECT By selecting one of the three Hazy aspect codes all the samples with this aspect code are displayed in the table also in case of
12. 15 1 1 1 3 EDTA mode EDTA mode is used for undiluted samples collected in tubes with EDTA anticoagulant The samples are automatically diluted on the StaRRsed Auto Compact during aspiration The usual amount of EDTA in sample tubes is 1 8 mg per 1 ml blood 1 ml of blood weighs ca 1060 mg and the concentration of EDTA is therefore 0 1796 and well within the requirements for the EDTA mode on this instrument Bidirectional Citrate mode StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Glossary of Terms 15 1 1 1 4 ESR ESR is short for Erythrocyte Sedimentation Rate It is the amount of sedimentation setting of erythrocytes red blood cells in a blood column during a specified time H 15 1 1 1 5 Hazy A sedimentation is reported to be hazy when the boundary between blood plasma and erythrocytes can not be defined clearly 15 1 1 1 6 Host In this manual the term HOST is used to indicate the computer system and associated software LIMS that provides the sample management for the laboratory 15 1 1 1 7 IVD IVD is short for In Vitro Diagnostic This kind of diagnostic is performed on biological samples in a test tube or more generally in a controlled environment outside a living organism n vitro means in glass in Latin M 15 1 1 1 8 MRN MRN is short for Master Registration Number It is used as an identification number for any manual for Mechatronics products 15 1 1 1 9
13. 8 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Introduction 1 INTRODUCTION The StaRRsed Blood Sedimentation Rate Instrument hereafter called StaRRsed Auto Compact is an in vitro diagnostic medical device that automatically carries out the erythrocyte sedimentation rate analysis according to the Westergren method conforming to CLSI approved standard H02 A5 using closed sample tubes filled with citrate or EDTA blood The StaRRsed Auto Compact is an advanced ESR system that offers many unique features and benefits over the traditional ESR procedures Automating this method has the following advantages e The Westergren pipettes are always filled to the correct level e Using closed sample tubes reduces the possibility of contamination for the user and environment e Standard glass Westergren pipettes are used in which the measurement can be corrected to a constant temperature 18 C Celsius Even small ab normalities can be detected over a longer period of time irrespective of where and when the blood sample was taken e Every sedimentation measurement is directly linked to an identified sample so that a manual work sheet is unnecessary Patient ID errors are reduced to a minimum by using the bar code reader e Inthe EDTA mode the accuracy of dilution of EDTA blood with citrate is considerably better than manual dilution achieved either by tipping off or using evacuated blood collectio
14. 9 IVD 125 L Leaking pipettes 81 Level 4 maintenance 91 Limit error settings 65 Limitations 71 Linked QC ID s 24 32 40 73 Liquid level sensor not sensing 82 Page 127 Index Liquid levels 69 M MAINTENANCE 88 Maintenance info 50 58 Maintenance info overview 59 Maintenance screen 18 20 50 Manual input sample ID 21 Measure station 20 Monitoring measurement quality with StaRRsed Control 71 MRN 125 MSDS 125 N New reagent input 49 New reagent input cont 49 O One air bubble about 5 mm under meniscus e 83 One air bubble rising in pipette 84 OPERATION 68 P Pipette information 23 Pipette looks like zebra crossing 82 Pipette 21 Power failure 77 Power up sequence 68 Prime Clean 50 51 68 95 96 98 101 107 Prime all units 52 Prime de ionized water 52 Prime Diluent 52 Prime Disinfectant 52 Prime Rinse solution 51 Prime Saline 51 Priming the fluid system 68 Protocols 61 Q QC abnormal results graph 38 QC abnormal results table 35 QC abnormal results screen extended 37 QC Error messages 74 QC normal results graph 34 QC Normal results table 32 QC normal results screen extended 34 QC Result analysis 41 75 QC Results 72 74 Page 128 mechatronics QC Results screens 24 32 74 QUALITY CONTROL 71 Quality control procedure 73 Quality control tro
15. IE 56 5 5 4 Display maintenance history ssssseeeeeennnm e 57 5 5 5 Lucas a ue Eqiesme 58 5 5 5 1 Maintenance info overvlew ENEE 59 5 5 6 Kleer ege 59 5 5 7 End of day wash opttons ee 59 5 5 8 End of day wash schedule settings NENNEN 60 5 6 Settings screen secco emt esesbnatedebr titer Brblesub bte bi Hirst ms tun UU mu ExU bM ocean aes 60 B SEVICE SCEE o 6ileond e aea ai etai b eee ee eee i eM 60 REPO Hee M 61 erte DEE cT n rr 61 6 2 Result due mr S 62 6 2 1 Report 60 Minute mode 62 6 2 2 Report 30 Minute mode rer rmt nni ere rk i eius 63 6 2 3 EE 64 6 2 3 1 ESR Error and Warning code messages 64 6 2 4 Limit error Setting EE 65 6 2 5 EEGENEN tee 65 6 2 6 Aspect HAZY ER Oo eng 66 6 2 6 1 Analyser HAZY code messages ENEE 67 Ta OPERATION WE 68 Bd e E TN rnc E 68 7 1 1 eege 68 Version 1 07 MRN 074 EN mechatronics Contents 7 1 2 ureil e ugn 68 7 1 3 Priming the fluid system EE 68 T2 Fill el 69 7 2 1 Be Bie BEE 69 7 3 Checks during operation EE 69 Tahe ie KEE 70 7 4 1 End of day wash procedure kee 70 7 4 2 Turn Ee EE 70 8 QUALITY CONTROL peececce pnr pe Eon ce toes cepted cet 71 Mesue e T C H 71 8 2 Monitoring measurement quality with StaRRsed Control sssse 71 8 2 1 lan Wen E 71 8 2 2 Expected value TANOG
16. MSDS MSDS is short for Material Safety Data Sheet In this type of MSDS all kind of important data can be found on reagents T 15 1 1 1 10 Temperature correction The sedimentation of blood cells is a temperature dependent process To achieve comparable results temperature correction should always be used The ESR results are then corrected to the value they would have been at the standard temperature of 18 3C Page 125 Glossary of Terms U 15 1 1 1 11 Unidirectional Unidirectional communication means that there is only one way communication from the StaRRsed Auto Compact to the HOST Only sample results and result related messages are send W 15 1 1 1 12 WI WI is short for Work Instruction and is used with an index number for a range of work instructions Page 126 R mechatronics StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics 16 INDEX 3 30 Minute method 62 63 6 60 Minute method 62 63 A Air bubbles 64 69 82 Analyser 67 Appendix Error list Auto Compact 114 APPENDIX FOR STARRSED AUTO COMPACT 113 Aspect Hazy 31 66 AUTO COMPACT PROGRAM 18 B Bidirectional 125 C Carousel 20 Check list 68 Check or replace sample probe or outer needle 89 Check sensors 50 54 Check the sensors in service mode 90 Checks during operation 69 Citrate mode 125 Cleaning liquid separator 91 Close 59 Control pipett
17. Me E 72 8 2 3 Temperature correction P 72 8 2 4 Usage ON ON Ss deiude bias iicet tuas Manes te eda estu Dudas ti acs 72 8 2 5 Quality control Drocedure ENNEN 73 8 2 6 QG TSS UNG m 74 8 2 6 1 QC Error messages uscire mr dign de ete enaeenaiess 74 8 25 2 QC EE 75 9 WASTE DISPOSAL cp 76 9 1 Replacing the waste E 76 10 DATA SAFETY MANAGEMENT irent rna p nne ure h kx Rn rh nnne ete ER kx Rn RR pene SEEEuE 77 NNN Ge e TEE 77 11 TROUBLE SHOOTING sensus nina abu cacesancnesescessecetasasensteceeaetacatenensecieeesaxesacanansens 78 11 1 X General error procedure ENEE 78 112 Flushing QUIS eege 78 T13 Reagents Mc 79 11 3 1 Reagents Ed E 79 11 4 ee 79 11 5 Fill time Out error ccm 80 11 6 Hazy 2 0 eege 81 11 7 Leaking pipettes eee tc 81 11 8 Liquid level sensor not sensimg ENNEN 82 EU EE dio c E 82 11 9 1 Pipette looks like zebra crossing ANEN 82 KE EN ene e EE 83 11 9 3 One air bubble about 5 mm under mentscus sssssnnnneeesseseerrrrrrreserrrrrre e 83 11 9 4 One air bubble rising in pipette ssessssnsnnerneeeseeenerrnnrnserrrrrrnnnnnssesserrrnne 84 11 9 5 Small air bubbles rising in pipette ssssssnnnnneneseeennrrnnrrserrrrrrrnnnrssrrnernnne 84 11 9 6 Random air bubbles in pipette n sseessenesnnrrneneseeernnrrnnreserrrrrrrnnnrssrr
18. PRIME DILUENT function 7 Wipe outer surface and stainless steel plate below the pipettes with disinfectant Page 98 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN R mechatronics Work instruction StaRRsed Auto Compact mechatronics Work instruction Number 191 Page 1 of 3 Purpose Weekly maintenance Safety Bio Hazard area Instrument Compact Revision 001 March 2014 Prepare disinfectant if not already prepared Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Clean Fill nozzle Disassemble the fill nozzle Assemble fill nozzle 1 Turn the holder to the right 1 Connect the silicon tube to the fill 2 The fill nozzle can now be removed nozzle 3 Disconnect the silicon tube from the fill nozzle 2 Put the fill nozzle into the holder e 3 Push the fill nozzle upwards and The use of a toothbrush and detergent is turn the holder to the left recommended 1 Carefully scrub the fill nozzle inner part 2 Use a tissue to dry the fill nozzle StaRRsed Auto Compact Instructions For Use Page 99 Version 1 07 MRN 074 EN R mechatronics Work instruction StaRRsed Auto Compact 2 Clean Liquid separator Removing 1 Open the left cover and remove the waste container The liquid separator is now visible 2 Liftthe stainless ste
19. Page 87 Maintenance 12 MAINTENANCE The StaRRsed Auto Compact is an analyzer that operates with considerable amounts of whole blood virtually undiluted and stores it in a pipette for one hour For this reason instrument maintenance is of the utmost importance Rm mechatronics To maintain the maximum reliability of the instrument the maintenance procedures must be strictly followed All procedures are based on a number of samples Maintenance levels WI Work instruction Daily WI 187 Daily maintenance on page 98 Weekly WI 191 Weekly maintenance on page 99 Level 4 Maintenance WI 193 level 4 maintenance on page 102 Every 3500 samples Level 3 Maintenance WI 194 Level 3 maintenance Every 10000 samples 12 1 Daily The purpose of the daily maintenance is to keep the instrument clean and contamination as low as possible Clean all parts that are exposed to blood wipe the outer surface and the stainless steel plate below the pipette belt See WI Daily maintenance on page 98 Page 88 SiaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Ro mechatronics Maintenance 12 1 1 Check or replace sample probe or outer needle A faulty or broken needle can cause a fill time out error or a dilution error Inspect sample needle condition each day clean if necessary If necessary replace the sample probe or outer needle Remove the top cover from the Rack
20. Press Refresh to refresh the list of available files In the window Sample ID type the sample ID information and press Search Press Options for the following search options e Show today s results e Show today s results from a selected time frame of the day e Show results of a number of past days Default value is set for 7 days e Show results of a specific day e Show results of the range between the first selected date to the next selected date Select in the table a Sample ID and click the button DISPLAY FULL PATIENT RESULT on page 27 for more detailed information of the selected sample In the header of the table the names of the columns are shown Double click the header of any column to sort the table by this column in ascending order Page 26 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Rm mechatronics Auto Compact program 5 3 2 1 Display patient results v 2 Sample History fe Reagents Maintenance Settings Service B IB peseequees qeerepeerapeeeepseerequeeregeeee LKE ELSE p D 50 60 70 90 100 110 120 130 140 150 160 170 1850 190 200 mm 130 Aspect ER emie ESR 60 min Samole ID code men E T Corr mm H0 90331302 les ss 150 z ESR time Ditution Temperature ane tk o LL Ss ez 1707 131 01 2012 06 43 16 Gy 102 124 E 180 Error code 190 pim Send patient result to HOST 2007 EI LS In the window Select date to show results double click on the fil
21. Serial output MECHATRONICS 01 bidirectional MECHATRONICS 02 unidirectional Sysmex SE 9000 Sysmex SE 9000 unidirectional Sysmex R 3500 Sysmex R 3500 unidirectional Compact bidirectional 9 Compact unidirectional String format for StaRRsed 10 StaRRsed Ill V14 11 Vesmatic 12 Sedimatic 15 13 Sedimatic 100 14 Opus bidirectional 15 Advia 120 bidirectional 16 Advia 120 unidirectional ON OO PO NM The protocol can be set in tab SERVICE Serial output settings After selecting a protocol save the new settings by pressing the Save setting key StaRRsed Auto Compact Instructions For Use Page 61 Version 1 07 MRN 074 EN Rm mechatronics Reporting 6 2 Result Printout The results of the ESR measurements are send to the printer The layout of the report depends on the selection of the 60 or 30 minute method 6 2 1 Report 60 Minute mode Colums Patient number Not corrected 30 minute ESR result only in use if 30 minute mode is active Not corrected 60 minute ESR result 60 minute ESR result in millimeters corrected for 18 C only in use if temperature correction is active Aspect clear hazy Manually entered code number Sedimentation pipette number number on the pipette belt Actual sedimentation time in minutes 9 Temperature in degrees Centigrade 10 Error message if the Analyser detects an error 11 EDTA mode Pont gt ONO REPORT EXAMPLE Not to scale StaR
22. Undo the sample probe 3 Pull the outer needle complete with sample probe together out the needle assembly 4 Mark each tube for easier reconnecting to the correct nipple 5 Disconnect the tubes from the outer needle Needle exchange NO OP com gt 8 9 Install new sample probe ESRIO50909 together with a new outer needle VERA059009 Slide the new sample probe into the new outer needle Make sure the Sample probe has a new O ring QWLV050003 Install new sample probe ESRIO50909 together with the new outer needle Put the sample probe in the outer needle Replace the needles onto the needle assembly Tighten the sample probe Do not over tighten the sample probe in the T piece Y piece or it Will crack or strip the threading inside the block Page 110 Replace the correct tubes on the outer needle Fasten the outer needle bolt Do not over tighten the screw 10 Replace the cover on the Rack unit SiaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Work instruction StaRRsed Auto Compact mechatronics Work instruction Number 192 Page 1 of 2 Purpose Fill and Clean with adapter Safety Bio Hazard area Instrument Auto Compact Revision 001 September 2012 Cleaning agent preparation Auto Compact Fill and clean This cycle takes about 90 minutes 1 Fill the clean adapter VERA119002 with hot de ionized water till the f
23. Version 1 07 MRN 074 EN Rm mechatronics Auto Compact program 5 5 1 Prime Clean tl History fe Reagents s Maintenance Settings w Service 1 l d i Wie IA EI When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE All maintenance functions for the fluid system are grouped under button PRIME CLEAN on page 51 After each reagent change the fluid system must be primed to fill the relevant tubes with reagent and remove air This is also part of the daily start up Use the applicable button to perform the automatic priming cycle for this reagent 5 5 1 1 Prime Rinse solution PRIME RINSE SOLUTION After each measurement the pipettes are washed and dried automatically 5 5 1 2 Prime Saline e PRIME SALINE After each aspiration the outer needle sample probe and fill nozzle are washed with saline StaHRsed Auto Compact Instructions For Use Page 51 Version 1 07 MRN 074 EN mechatronics Auto Compact program 5 5 1 3 Prime Diluent PRIME DILUENT The Diluter prime cycle is 5 strokes of the syringe 5 5 1 4 Prime de ionized water e PRIME DE IONIZED WATER After each aspiration the fill nozzle is flushed with de ionized water 5 5 1 5 Prime Disinfectant PRIME DISINFECTANT During a pipette rinse cycle a small amount of disinfectant is flushed around the bottom of the pipette and into the waste system 5 5 1 6 Prime all units When the StaRRse
24. entire system is washed automatically If there is no liquid flow e Check that the peristaltic pumps are running If the pump tubes are worn or leaking replace the tubes e Check that the pump tubes are installed correctly e Check the tubes between the containers and pumps valves e Unscrew the cap from the container Check the pick up tubes in the container and that there is enough liquid in the container e Check the tubes for blockages or kinks Page 78 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Trouble shooting 11 3 Reagents Check the expire dates of the reagents regularly Do not use the reagents if expired Note If expired reagent has been used accidentally the results obtained with these reagents may only be used when the expire date was not exceeded more than 30 days DILUENT is sensitive for bacterial growth The solution should be discarded if it becomes turbid or infected When using the small onboard containers clean the DILUENT container thoroughly with 10 Na hypochlorite Make sure that the container has been thoroughly rinsed after cleaning 11 3 1 Reagents alarm The software checks the bottle status before starting a new rack If a level alarm is ON it will not process the new rack If an alarm comes ON during a rack it will finish to aspirate that rack 10 samples max Washing dirty pipettes always continues as to avoid that the samples are left in the
25. incorporated in the StaRRsed barcode and the accepted range of deviation The applicable values for the acceptable range depend on the user setting ESR 60 Uncorrected result from QC sample ESR 60 T CORR Temperature corrected result from QC sample T Temperature at which the sample was measured Error Warning Only special QC errors are mentioned here general ESR warnings errors are mentioned in the next column After these columns additional data is shown pipette number dilution rate ESR30 ESR time and Aspect Scroll to the right Results are always shown with and without Temperature correction independent of the setting TEMP CORRECTION ON or OFF The following options can be selected RELATED PATIENT RESULTS This screen is simular to the Display sample history screen The background colour of the patient history table is switched to light yellow to distinguish these QC related patient results from the standard patient history table Depending on the frequency of QC samples related patient results may span over multiple days and are listed per date EXPORT TO EXCEL CSV Results can be exported to a CSV file and imported in an MS Excel file for further analyses BATCH All used batches of StaRRsed Control are shown results are shown for chosen batch ID CLOSE Return to History Screen StaRRsed Auto Compact Instructions For Use Page 33 Version 1 07 MRN 074 EN mechatronics Auto Compact p
26. instruction StaRRsed Auto Compact 13 WORK INSTRUCTION STARRSED AUTO COMPACT Work instruction section StaRRsed Auto Compact Instructions For Use Page 97 Version 1 07 MRN 074 EN Work instruction StaRRsed Auto Compact Rs mechatronics mechatronics Work instruction Number 187 Page 1 of 1 Purpose Daily maintenance Safety Bio Hazard area Instrument Compact Revision 001 March 2014 Prepare disinfectant if not already prepared Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Go to tab MAINTENANCE and perform the End of day wash procedure when Fill amp Clean is used End of day wash is not required 2 Check system for leakage e Inspect the peristaltic pump tubes and connections for leaks e Check that liquid does not run back into the supply bottles after the pumps have stopped 3 Clean and inspect the sample needle e Inspect sample needle condition If necessary replace the sample probe or outer needle See Work Instruction Sample probe or outer needle replacement e Clean the outer needle with disinfectant 4 Check tubing from the syringe for trapped air bubbles e Check Diluent syringe for trapped air bubbles 6 Iftrapped air bubbles are found go to tab MAINTENANCE click button PRIME CLEAN ON PAGE 51 and perform the
27. of time the separator is getting dirty and therefore it needs to be cleaned weekly Detailed instructions of this procedure can be found in the Work Instruction WI 196 Cleaning liquid separator on page 112 Symptoms of a dirty separator 1 Separator errors 2 Foam in the separator 3 Waste pump cannot sufficiently remove the waste from of the separator 12 3 Level 4 maintenance The purpose of level 4 maintenance is to carry out the daily weekly maintenance and replace the pump tubing bacterial filters and the Fill nozzle O ring After replacing those items the instrument needs a Fill and Clean sequence to clean the pipettes Over a monthly period protein builds up in the Westergren pipettes and needs to be deproteinized using a strong cleaning agent Detailed instructions of this procedure can be found in the Work Instruction WI 193 level 4 maintenance on page 102 12 3 1 Rinse pump tube replacement New rinse pump tube assembly ESRIO90902 Rin SOLU gt N ALINE ene meapiossing tiaa map zl 4 SC Wy New tube replacement 1 Open left cover Pull pump tube slightly downwards and at the same time towards the front of the unit to release the tube out of the pump plate holder Remove the old tube from the peristaltic pump rotor Disconnect the tubing at both ends of the tube connectors Connect new tubing to both ends of the connectors Place one end of the tube in the pump plate holder Pull the new
28. pipettes Reagents alarm is also set when the expire date of the reagent is exceeded or opened more than three months The message Not allowed now See REAGENTS appears Processing of new samples is stopped 11 4 Separator error If it takes too long for the waste pump to empty the liquid separator the system generates a separator error Extensive foam build up in the liquid Check the separator assembly and connections for separator possible air leaks Waste tube between liquid separator and Replace the tube waste pump is blocked Waste tube between waste pump and Replace the tube waste container blocked Waste pump failure Exchange the waste pump cassette If the error returns call for service Electrical bridge between the waste level Clean liquid separator see WI 196 Cleaning liquid electrodes separator on page 112 StaRRsed Auto Compact Instructions For Use Page 79 Version 1 07 MRN 074 EN Rm mechatronics Trouble shooting 11 5 Fill time out error Normally the fill sequence takes about 3 seconds However if the fill sequence exceeds 10 seconds a fill time out error will be generated The Compact aborts the fill sequence and this error message will be shown on the display and reported to the printer Fill time out error may be caused by 1 Blood clots or rubber debris from the tube cap in the sample e Check the condition of the outer needle e Check the mixing time of the tube SETTINGS
29. position FILL E97 Position motor error Not on position IN E98 Position motor error Not on position IN E99 Position motor error Not on position MIX E100 Position motor error Not on position MIX E101 Position motor error Not on position FILL E102 Position motor error Not on position MIX StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Appendix for StaRRsed Auto Compact See E61 See E61 See E61 See E61 Gripper did not reached the MIX position Starting point FILL position Gripper did not reached the MIX position after reading the barcode Starting point FILL position Gripper did not reached the FILL position after mixing the rack Starting point MIX position Gripper did not reached the FILL position Starting point last sampled tube Gripper did not reached the IN See E61 catch position Starting point MIX position Gripper did not reached the IN catch position after gripper error Starting point MIX position Gripper did not reached the See E61 See E61 MIX position Starting point FILL position Gripper did not reached the See E61 MIX position Starting point IN position Gripper did not reached the See E61 FILL position Starting point See E61 last sampled tube Gripper did not reached the MIX position Starting point FILL position Page 123 Appendix for StaRRsed Auto Compact E104 Needle unit not in
30. rack history file StaHRsed Auto Compact Instructions For Use Page 29 Version 1 07 MRN 074 EN Auto Compact program 5 3 3 1 Display rack status More detailed information of the samples in the selected rack is shown in the status table The last 10 racks are stored and can be selected The Clear rack history button will clear the contents of the rack history file and restart to build up a new rack history file Page 30 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Auto Compact program 5 3 4 ESR Statistics screens m4 ESR Statistics e Daily mean mm O Hazy C Dilution Q Bubbles on top 95 ESR errors O Number of samples Dilution error 10 diluter setting Period From 2 12 Oct 11 f E Jj 1 month s back Export to Excel CSV 0 71 1 1 1 D D 1 1 1 1 Close 02 Sep 11 04 Sep 11 06 Sep 11 08 Sep 11 10 Sep 11 12 Sep 11 15 Sep 11 x Date A statistical graph is produced over a selected period Make a selection of the following graphs Daily mean mm Use this to check variations in the daily mean ESR Hazy 96 Increasing hazy aspects are an indication for contamination of the instrument see Aspect Hazy on page 66 Dilution 96 Increasing dilution errors indicate the need for maintenance of the diluter system Bubbles on top 96 Increasing samples with bubbles indicate the need for maintenance of the aspiration syste
31. tube manufacturer Close the tube with the mixture and invert at least 12 times then place the sample into the analyzer 1 When using LAB ID Link the Lab ID with StaRRsed Control Sample ID see chapter Linked QC ID s on page 40 Attach the lab ID label on the tube on top of the original StaRRsed Control label 2 Invert the StaRRsed Control tube until packed cells have been completely re suspended Continue mixing for 30 seconds at least 12 complete inversions Avoid foaming DO NOT VORTEX NOTE To ensure consistent and reproducible results the Control material must be thoroughly mixed and handled in the same manner each time Place StaRRsed Control tube immediately after mixing into the analyzer 4 Start the Sample mode The StaRRsed Control sample is processed in the same manner as a patient sample Depending on the settings in QC settings a request and or result is send to the LIMS 5 Restore tube after each use at 18230 e For detailed information see the StaRRsed Control Package Insert The contents of one tube of 5ml is sufficient for three Control samples Do not mix residual material with material from other tubes Do not re use empty tubes The software interface is described in the chapter History screen on page 24 StaRRsed Control should be disposed of as medical waste StaRRsed Auto Compact Instructions For Use Page 73 Version 1 07 MRN 074 EN mechatronics Quality control 8 2 6 QC Result
32. tube over the peristaltic pump rotor N NO P ro StaRRsed Auto Compact Instructions For Use Page 91 Version 1 07 MRN 074 EN mechatronics Maintenance 8 Pull pump tube slightly downwards and at the same time towards the back of the StaRRsed Auto Compact If the tube is not fitted correctly or is worn the following symptoms can occur Liquid flowing back into the container First glass tube on the pipette belt is not washed sufficiently Note The wider bore tube is for the rinse pump 12 32 Saline pump tube replacement New saline pump tube assembly ESRI090903 Rip e SOLU gt N ALINE gg geng t Lanng rasens a onde moage dion saine more po mega uge ac n sain 4 shores Y ze New tube replacement 1 Open left cover 2 Pull pump tube slightly downwards and at the same time towards the front of the unit to release the tube out of the pump plate holder Remove the old tube from the peristaltic pump rotor Disconnect the tubing at both ends of the tube connectors Connect new tubing to both ends of the connectors Place one end of the tube in the pump plate holder Pull the new tube over the peristaltic pump rotor Pull pump tube slightly downwards and at the same time towards the back of the StaRRsed Auto Compact D 0 0c amp If the tube is not fitted correctly or is worn the following symptoms can occur Liquid flowing back into the container e Sample needle is not washed suf
33. with QC Settings If results are incidentally out of range it is advised to perform a daily maintenance and or fill and clean step and then perform another QC sample step before releasing patient results If results are not send to the LIMS QC Results can be exported to MS Excel CSV files for further analysis in lab s own Quality Control data system StaRRsed Auto Compact Instructions For Use Page 75 Version 1 07 MRN 074 EN mechatronics Waste disposal 9 WASTE DISPOSAL The waste container has a level sensor and as soon as the level sensor generates a waste error the waste container must be emptied The waste must be treated as potentially infectious biohazardous material and disposed of according to local regulations Preferably discard the complete waste container and replace it with a cleaned one Press ESC to clear the error Disclaimer Check your local environment rules about discharging the waste If the waste line is to be connected to a centralised waste collection system the following requirements must be met 1 Waste tube must not exceed 5 meters or 18 feet in length 2 Drain height must not be higher than the original waste container inside the instrument Disclaimer Check the specifications of the central waste system for rules about discharging the waste 9 1 Replacing the waste container Lift the left cover and pull the waste container forwards Unscrew the cap Place the new waste container an
34. 0 100 120 140 160 180 200 Measure head start position wrong prantos gotanatagotanata 0 20 40 60 80 100 120 140 160 180 200 NOTE Clean sensors first before executing this function NOTE When a test pipette is installed at the measuring position the result of the test pipette is displayed in the field ESR mm Note When the sensor is out of range and the light is red the sensor values can be checked by turning on the service mode StaRRsed Auto Compact Instructions For Use Page 55 Version 1 07 MRN 074 EN Rm mechatronics Auto Compact program When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE All errors that occurred during operation are logged automatically This list can be used by field engineers to check check the status of the instrument and locate possible problems This log can be saved e g to a memory stick by clicking button Save As Page 56 SiaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Rm mechatronics 5 5 4 Display maintenance history C o Sample iff History E Elle iil k Reagents Maintenance Settings 12 Oct 11 13 56 19 Fill amp Clean finished 12 Oct 11 13 56 16 Fill amp Clean executed 12 Oct 11 13 55 18 Fill amp Clean finished 12 Oct 11 13 55 18 Fill amp Clean executed 12 Oct 11 13 55 13 Fill amp Clean cancelled 12 Oct 11 13 53 37 Fill amp Clean executed 12 Oct 11 11 03 47 Fill s
35. 1 5 2 5 Pipette D 21 5 2 6 Rack shee ec 21 5 2 7 Sample mode button uice rre ttr ect rette keit resin 21 5 2 B Version information eet 21 5 2 9 Manual input sample ID ssssessnneneneesseeenerrrnrrssererrrnrrrssertnnnrnnntnsrerrnnrnnee nnn 21 5 210 ue Elei KE 22 521l II I e crm 22 5 2 12 Sample screen with keyboard sssssseeesessssssserrrrrssseerrnrrrnnrsstrtennrnnnensreennne 22 5 2 13 Pipette information E 23 53 History SEL E 24 5 3 1 Display pipette E oer emet tei eh titu ra pk tit a Sa e RARE S 25 5 3 2 Display Sample history sssssnnnneeeeseennerrnresseeernrrrrrtrsstrtntrnnnnssstnnernnnnnsseennne 26 5 3 2 1 Display patient results EEN 27 5 3 3 Display raslc HISIODV A 29 5 3 3 1 Display e 30 5 3 4 ESR Statistics Sree M erein R aeea EEEE EEA 31 5 3 5 OG Results SClBell8 uu ooa pe ped t ndba ps eaa ER EE E 32 5 3 5 1 QC Normal results table unn 32 5 3 5 2 QC normal results screen extended sssseees 34 5 8 5 8 QC normal results orapb EEN 34 5 3 5 4 QC abnormal results table reta treten ttr reraane 35 5 8 5 5 QC abnormal results screen extended uk 37 5 3 5 6 QC abnormal results graph EEN 38 5 3 5 7 Display sample history OC 39 E Bee Eelere ne A0 5 3 5 9 QC E 41 5 3 6 History analyse EE 41 5 3 7 History analyse results high dilution
36. 4 vols with sodium citrate anticoagulant diluent 1 vol Automatic dilution 4 vols blood 1 vol sodium citrate diluent 3 296 NaCl accuracy 3 Reported result mm after 1 hour Reagents Reagents used Reagent barcode label information Blood volume QRR 010931 Diluent QRR 010947 Disinfectant QRR 010933 Saline QRR 010934 Rinse solution De ionized water Code39 Aspirated blood volume per sample 1 4 ml in EDTA mode 1 6 ml in Citrate mode StaHRsed Auto Compact Instructions For Use Page 13 Version 1 07 MRN 074 EN Instrument description Rack and tube types mechatronics Rack types Abbott CD3500 3700 Abbott CD4000 Sapphire ABX Pentra 80 ABX Pentra 120 Bayer Advia Coulter LH750 DXH800 Coulter HmX Sysmex sample rack low profile Sample tube types Most commonly used brands types Closed tubes with concentric cap only Barcode reader Barcode reader type CCD Reading capabilities Most common barcode labels Code389 ITF Industrial 2 or 5 CodaBar EAN UPC and CODE128 Data storage Storage medium 30 Gb Hard disk on external PC Storage capacity indication Page 14 approx 5 Mb per 1000 samples results and raw data StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics 2 2 Technical specifications contd StaRRsed Compact environment Installation Less than 65 dB
37. A Sound level Environment temperature 18 28 Relative humidity 10 9076 StaRRsed Compact Mains voltage 100 240V 50 60Hz Fuse 20 x 5 mm Slow blow 220V 2 5 Amp Slow blow 110V 5 0 Amp Power consumption sn 60 VA Maximum 500 VA Heat output Standby 70 Watt Full operation 360 Watt Rack unit Mains voltage Power consumption Weight StaRRsed Auto Compact overall dimensions Dimensions Width Height Depth Weight StaRRsed Auto Compact table size Table size Min Width Exclusive space for PC Width Including space for PC Depth StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN 12 Volt DC from the StaRRsed Auto Compact 50 VA 21 5 Kg 1 100 mm 770mm 660 mm 70 kg 1 100 mm 1 500 mm 660 mm Page 15 mechatronics Installation 3 INSTALLATION The instrument must be unpacked installed and checked by a trained engineer prior to first operation Detailed installation instructions are given in the StaRRsed Auto Compact Installation manual Page 16 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics General safety instructions 4 GENERAL SAFETY INSTRUCTIONS The instrument described in this manual is designed to be used by properly trained personnel only For the correct and safe use of this instrument it is essential that both operating and servicing personnel follow generally accepted safety procedures in additi
38. Control level A are shown Display Results table QC sample ID Read from the barcode The original StaRRsed Control barcode batch number Linked lab ID The Lab ID is given if it is linked to the StaRRsed Control sample ID Sampling date The date and time when the QC sample was aspirated Expiry date If the StaRRsed Control expiry date is exceeded it is not possible to continue with this QC sample The sample is not measured but the failed attempt is logged in the table Expected ESR This is the temperature corrected mean value incorporated in the StaRRsed barcode and the accepted range of deviation The applicable values for the acceptable range depend on the user setting ESR 60 Uncorrected result from QC sample ESR 60 T CORR Temperature corrected result from QC sample T Temperature at which the sample was measured Error Warning Only special QC errors are mentioned here general ESR warnings errors are mentioned in the next column After these columns additional data is shown pipette number dilution rate ESR30 ESR time and Aspect Scroll to the right Results are always shown with and without Temperature correction independent of the setting TEMP CORRECTION ON or OFF The following options can be selected Page 36 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN RR mechatronics Auto Compact program RELATED PATIENT RESULTS This screen is simular to the Displ
39. GENERAL SETTINGS MIXING INTERVAL lt default 90 sec gt 2 Filling procedure stopped by operator 3 Insufficient sample volume e Should be at least 1 4 ml 4 Faulty fill nozzle or fill nozzle washer O ring e Check fill nozzle and washer O ring 5 Incorrectly adjusted sample probe depth e Check needle depth SETTINGS GENERAL SETTINGS SAMPLE PROBE DEPTH lt default 5 mm gt 6 Noor poor vacuum e Check vacuum MAINTENANCE CHECK SENSORS CHECK FLOW SENSOR Page 80 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Rm mechatronics Trouble shooting 11 6 Hazy reports Hazy reports are usually caused by build up of proteins on the inner wall of the pipettes Another cause is growth of micro organisms in the diluter system It is extremely important that the system is kept sterile First run an extra Fill amp Clean sequence then check after a day s run if haziness is decreased When there are still many reports it is recommended to fill the diluter system with a 5 chlorine solution See WI 178 Hazy problem on page 109 A picture example of haziness 11 7 Leaking pipettes 1 Check for particles like specks of dirt or hairs in the pipette valve 2 lf no particles are found replace the valve tube and valve body StaRRsed Auto Compact Instructions For Use Page 81 Version 1 07 MRN 074 EN Rm mechatronics Trouble shooting 11 8 Liquid level sensor not sensing 1 Liquid in th
40. INSTRUCTIONS FOR USE STARRSED AUTO COMPACT INSTRUCTIONS FOR USE Version 1 07 MRN 074 EN IET e Wall i H dr HEI Wag H Hit LUI d NE EE d Master Registration Number MRN 074 EN mechetronics Manufacturer Mechatronics Manufacturing B V Phone 31 0 229 29 11 29 Fax 31 0 229 24 15 34 E mail support mechatronics nl Internet http www mechatronics nl P O Box 225 Postal address 1620 AE Hoorn The Netherlands De Corantijn 13 Office address 1689 AN Zwaag The Netherlands Copyright Mechatronics BV All rights reserved Subject to changes without prior notice Issued by the After Sales Department of Mechatronics mechatronics Document history overview Document history overview MRN 074 EN Published date 15 October 2014 Date Revised Section s Section s Authorised unm e General safety instructions H Schavemaker Safety e Explanation of documentation Error list revised E21 E29 E32 added History screen Introduction of chapter H Schavemaker Quality Control Appendix Quality control Trouble shooting History screen Addition print result header H Schavemaker Maintenance Hazy aspect not screen suppressed in case of limit Maintenance error Error list Prime Clean text Maintenance items up to level 4 included Reagent installation Error 19 added July 2012 Reagents screen Reagent barcode reader H E van Dijk Reporting Limit error sett
41. Instructions For Use Version 1 07 MRN 074 EN mechatronics Work instruction StaRRsed Auto Compact e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FILL STOP SENSOR box Fill stop sensor FS 90 140 165 Diluter Start sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select DILUTER START SENSOR box Diluter start sensor 400 700 Measure sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK MEASURE SENSOR box Measure sensor MS 40 50 60 Temperature sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK TEMPERATURE SENSOR box Temperature sensor TS Room temperature Diluent flow sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK DILUENT FLOW SENSOR box Press test When test is finished signal Down and signal Up must be green Separator check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK SEPARATOR SENSOR box Separator sensor 200 600 gt 700 4 Final preparation 1 Go to tab MAINTENANCE and perform the End of day wash procedure when Fill amp Clean is used End of day wash is not required 2 Check system for leakage e Inspect the peristaltic pump tubes and connections for leaks e Check that liquid does not run back into the supply bottles after the pumps have stopped 3 Clean and inspect the sample needle e Inspect sample needle condition If necessary replace the sample probe or outer needle See Work Instruction Sample pro
42. L position E87 Position motor error Not Gripper did not reach the OUT See E61 on position OUT release position Starting point FILL position E88 Position motor error Not Gripper did not reach the MIX See E61 on position MIX position Starting point OUT position E89 Position motor error After an rack error the position See E63 Can t initialize motor due toa motor tried to initialise its possible hardware error home position but could not Please exit and then restart succeed due to a possible Auto Compact If this error fatal hardware error occurs repeatedly please note the error code before seeking assistance E90 Mixermotor error Can t Could not home mixer motor See E60 initialize motor due to a within a certain time limit possible hardware error E91 Can not discharge rack This error will be automatically e End pool full Endpool full remove racks cleared after removing the racks and the rack will be released E92 Position motor error Not Gripper did not reached the See E61 on position MIX MIX position to start a short mix Starting point FILL position Page 122 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN e Check Rack out sensor mechetronics E93 Position motor error Not on position MIX E94 Position motor error Not on position MIX E95 Position motor error Not on position FILL E96 Position motor error Not on
43. MRN 074 EN mechatronics Appendix for StaRRsed Auto Compact E70 Can t home mixer Rack Mixer motor send to home Check the position motor not on mix position position but position gripper motor is not on MIX position E71 Position motor error Not Gripper did not reach the MIX See E61 on position MIX position Starting point HOME position E72 Not on position Gripper did not reach its given See E61 position by the user E73 Position motor error Could not send the racks on Check the position motor Position motor is on IN the In pool to the first stop position position Could not start the conveyer belt motor because the position gripper is on the IN position E74 Position motor error Not Could not release the rack Check the position motor on position OUT from the gripper because the position gripper motor is not on the OUT position E75 Position motor error Not Could not send start the Check the position motor on position IN conveyer belt motor the rack into the gripper because the position gripper motor is not on the IN position E76 Can t start mixing long Could not start the mixer Check the position motor Rack not on mix position motor because the position gripper motor is not on the MIX position E77 Can t start mixing short Could not start the mixer Check the position motor Rack not on mix position motor because the position gripper
44. MRN 074 EN mechetronics Trouble shooting QC sample is not accepted and StaRRsed Control ID is not e Check barcode not performed known in LIMS A specific QC result cannot be Check Lab ID link History found in the list of results Deviating results Extra information EE QC result is not visible in QC The measured control values change abruptly up or downwards Systematic QC errors with a shift in control values QC results are out of range Do not compare 30 minute method with 60 minute method result The calculation method can give some deviation in the general QC results statistics The measured control values change gradually upwards or downwards Systematic QC errors with a trend in control values QC results out of the range or nearly out of the range Note on QC Errors Check clean instrument and perform a new QC sample If these errors persist perform maintenance step Compare only results from one batch If Lab ID is used check the linked StaRRsed Control ID Itis possible that a new batch is in use without changing to the new assayed mean value Irregular or insufficient maintenance can cause unnecessary QC errors and ESR errors warnings Error messages are only shown and stored in QC results and not send to LIMS QC result is given with the same general errors and warnings as a normal patient ESR result StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN
45. Rsed Date 20 05 14 Time 15 28 L1 234 5 8 7 8 9 1 1 _ 905001 84 75 CLEAR 17 60 23 EDTA 905002 14 13 Hazy lt 10mm 18 60 23 EDTA 905003 22 21 Hazy lt 25mm 19 60 23 EDTA 905004 67 61 Hazy gt 25mm 20 60 23 EDTA 905005 CLEAR 3 21 60 23 EDTA 905006 5 5 CLEAR 22 60 23 EDTA 079 905007 24 60 23 Too many borders found 905008 25 60 23 L err 84 75 200 EDTA 905002 905003 905004 Sample results with hazy aspect 905005 Sample result with a manual aspect where the manual aspect is shown as a number 3 in column 6 of this data record sample 905006 In this sample the dilution rate has a dilution failure of 21 and that is printed as EDTA 079 Page 62 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN R mechatronics Reporting 905007 Sample results with a text error This sample gives Too many borders found Result of a pipette possibly filled with air bubbles 905008 Sample result with a text error This sample is given limit error L_err 84 75 200 6 2 2 Report 30 Minute mode Columns Patient number Not corrected 30 minute ESR result only in use if 30 minute mode is active Not corrected 60 minute ESR result 60 minute ESR result in millimeters corrected for 18 C only in use if temperature correction is active Aspect clear hazy Manually entered code number Sedimentation pipette number number on the pipette belt Actual sedimentation time in minutes 9 Temperature
46. am description is valid for software up to version 5 01 Software version V5 00 and higher runs only on a Windows 7 PC 5 2 Sample screen Sample ist History i Reagents a m wr 1 30 min method AUD l Auto Compact v2 23 22 06 2010 12 29 44 The main menu is displayed during operation To access other menus select the required tab on the display and press the mouse button To access the other sub menus in the selected tab select the required button and press the mouse button The following screens are selectable via the associated tabs 1 SAMPLE screen on page 19 StaHRsed Auto Compact Instructions For Use Page 19 Version 1 07 MRN 074 EN mechatronics Auto Compact program HISTORY screen on page 24 REAGENTS screen on page 47 MAINTENANCE Screen on page 50 SETTINGS screen SERVICE screen OR wD The above picture is an example of the SAMPLE screen of the Compact in the normal operation mode If the Service mode button with light is shown in the Status line the Compact is running in the service mode The User Manual button is also in the status line Click this button to open the StaRRsed Auto Compact User manual When the Compact is running in the Service mode all kinds of settings can be changed and the instrument will run with the changed settings For instance when ESR time is set to 12 minutes the Carousel will move according this time setting to be in time at the measu
47. an error In the header of the table the names of the columns are shown Double click the header of any column to sort the table by this column in ascending order 5 3 9 History analyse error Analyse results is Tis Cp Sapel j Im j Ppette Tem Aspect Din Ermo P j j t onssa otpecooiseil 8 123 Teora Nocldpamafound M UU M GE Se 23306702 Aud S 04 27 LLL ERROR By selecting one of the error codes all the samples with this error code are displayed in the table In the header of the table the names of the columns are shown Double click the header of any column to sort the table by this column in ascending order StaRRsed Auto Compact Instructions For Use Page 43 Version 1 07 MRN 074 EN RR mechatronics Auto Compact program 5 3 10 History analyse warning Analyse results 2 F TT II Tene Ppette Temp Aspect Dn Em E IDN UDO UNI D WARNING By selecting one of the warning codes all the samples with this warning code are displayed in the table In the header of the table the names of the columns are shown Double click the header of any column to sort the table by this column in ascending order Page 44 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Auto Compact program 5 3 11 History sample analyse option day ei Search options Sample history opt
48. an value of chosen StaRRsed Control Shown as value e Calculated mean mean value of all QC results of the specific batch e Standard deviation the average deviation of all QC results compared with the expected ESR e Coefficient of variation ratio of the standard deviation to the expected ESR expressed in a percentage e Number of QC results This graph gives a first indication of the measuring stability of the StaRRsed Auto Compact Further analysis and identification of systematic errors have to be performed in the user s Quality Control System CLOSE Return to History Screen 5 3 5 4 QC abnormal results table N 05 01 2012 O7 23 5 03 02 2012 SEH 03 02 2012 37 10 LS 37 GF 10 me 37 4 10 s 03 02 2002 37 9 10 23 01 2012 08 16 5 03 02 2012 37 F 10 376 10 137 GF 10 ES EEGEN 03j02j2012 eo 37 f 10 slaislglsielelslelssleleislsaislsls mn zt 1601 201207 45 5 03 02 2012 37 f 19 13 01 201207 45 5 03 02 2012 37 4 10 25 01 201207 45 5 03 02 2012 37 44 10 P ELI8 Uncorrected QC resut is v 03 02 2012 37 4 10 moto 37 10 DI 37 4 10 03 02 2012 37 4 10 Im 37 4 10 e 37 10 O3j zjzoi2 tot sje gia ass es StaRRsed Auto Compact Instructions For Use Page 35 Version 1 07 MRN 074 EN mechatronics Auto Compact program The results from StaRRsed
49. ay sample history screen The background colour of the patient history table is switched to light yellow to distinguish these QC related patient results from the standard patient history table Depending on the frequency of QC samples related patient results may span over multiple days and are listed per date EXPORT TO EXCEL CSV Results can be exported to a CSV file and imported in an MS Excel file for further analyses BATCH All used batches of StaRRsed Control are shown results are shown for chosen batch ID CLOSE Return to History Screen 5 3 5 5 QC abnormal results screen extended m OC Statistics and Results alalelalal CG IER i 4 meg EL18 Uncorrected QC result is v n e ek After scrolling the general data from the QC results are shown StaHRsed Auto Compact Instructions For Use Page 37 Version 1 07 MRN 074 EN mechatronics Auto Compact program 5 3 5 6 QC abnormal results graph a OC Statistics and Results QC ABNORMAL Statistics amp Results Linked QC ID s QC results mm Display Calculated mean mm Mas C Results table Expected ESR mm Statistics graph Batch QCOE44AAQS ees arjo1s2012 1ojotjzot2 13 o1 2012 16jo1j2012 19jo1jzoi2 2240112012 2501 2012 zsforjnt2 DEG Date Calculated mean rm Standard deviation mm Coefficient of variation Number of OC results Displa
50. be or outer needle replacement e Clean the outer needle with disinfectant 4 Check tubing from the syringe for trapped air bubbles Check Diluent syringe for trapped air bubbles 6 If trapped air bubbles are found go to tab MAINTENANCE click button PRIME CLEAN ON PAGE 51 and perform the PRIME DILUENT function 7 Wipe outer surface and stainless steel plate below the pipettes with disinfectant e StaRRsed Auto Compact Instructions For Use Page 101 Version 1 07 MRN 074 EN RS mechatronics Work instruction StaRRsed Auto Compact RR mechatronics Work instruction Number 193 Page 1 of 5 Purpose Maintenance level 4 Safety Bio Hazard area Instrument Auto Compact Revision 002 March 2014 1 Clean Fill nozzle and exchange O ring Fill Nozzle Disassemble the fill nozzle Disassemble fill nozzle holder 1 Turn the holder to the right 1 Turn the holder to the right 2 The fill nozzle can now be removed 2 The holder can now be removed 3 Disconnect the silicon tube from the fill nozzle The use of a toothbrush and detergent is recommended 1 Carefully scrub the fill nozzle inner part 2 Useatissue to dry the fill nozzle Replace O ring Remove the O ring QWLV050004 Install new O ring QWLV050004 Page 102 SiaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Rm mechatronics Work instruction StaRRsed Auto Compact Assemble fill no
51. bes diluter system Fill nozzle motor is faulty Fill nozzle motor driver on nozzle board is faulty Fill nozzle is blocked Check home top sensor Outer needle motor is faulty Outer needle motor driver on needle board is faulty Outer needle is blocked Page 115 Appendix for StaRRsed Auto Compact E18 Carousel position error Check Rinse position Value of potentiometer does not match the value stored in memory of the current rinse position Drive motor did not move or motor is blocked E19 Drive motor timeout E20 Outer needle motor position error piercing error Outer needle could not go down all the way Piercing position sensor was triggered E21 No USB IO device detected Check USB IO Device settings USB IO Device enabled but not detected mechatronics Check if the rinse position is right Set correct rinse position and do a Learn carousel positions Check mechanical connection potentiometers Check the home sensor Motor is faulty Motor driver on drive board is faulty Check tube 1 position setting Tube 1 not aligned well Check piercing position sensor Check power to USB IO Device Check USB cable USB IO Device driver not installed Check USB IO Device settings E22 Waste bottle full Empty waste bottle and clear e Check level sensor error E23 Fill sensor out of range Check clean this sensor critical level Continuing co
52. compared with the Assay mean value e E116 QC is out of acceptable range The uncorrected and the corrected result are out of range e E117 Uncorrected QC result is out of acceptable range but corrected result is within range The uncorrected result is out of range but the corrected result is within range e E118 Uncorrected QC result is within acceptable range but corrected result is out of range The uncorrected result is within range but the corrected result is out of range See Quality control trouble shooting on page 85 and QC Results screen on page 32 for more details Page 74 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Quality control 8 2 6 2 QC Result analysis Authorized staff should identify and differentiate acceptable unacceptable random errors and trends and or shifts in systematic errors from the statistical data Depending on the users Quality Control Procedures analytical results could be accepted or rejected Changes in QC results can be gradual or abrupt Gradual changes can be caused by contamination and incidental environmental variations Abrupt changes can be caused by change of QC material batch or possible hardware errors If results are continuously out of range due to significant difference between calculated mean and control value but the statistics show precise results with small deviations it should be considered to expand the acceptable assay range
53. ctant in the system for 15 minutes Step 2 Take the diluent suction tube out of the disinfectant Wipe the tube clean and dry with a tissue Place the diluent suction tube in hot de ionized water 80 Use the PRIME DILUENT function After the prime sequence stops press PRIME DILUENT 5 times to fill the dispenser system with the hot water Step 3 Clean the diluent bottle s with the disinfectant Rinse the diluent bottle with hot de ionized water 80 Rinse the diluent bottle with diluent solution Refill the diluent bottle with new diluent solution Use the PRIME DILUENT function After the prime sequence stops press the PRIME DILUENT key 5 times to fill the dispenser system with the new diluent solution Step 4 1 2 3 Prepare a Fill and Clean arrangement Run the fill and clean sequence When all the pipettes are filled the needle goes back to the home position Remove the Fill and clean arrangement StaRRsed Auto Compact Instructions For Use Page 109 Version 1 07 MRN 074 EN Work instruction StaRRsed Auto Compact Rm mechatronics RR mechatronics Work instruction Number 189 Page 1 of 1 Purpose Sample probe or outer needle replacement Safety Bio Hazard area Instrument Auto Compact Revision 001 October 2012 Remove the top cover from the Rack unit 1 Unfasten the screw which prevent the outer needle to drop out of the assembly 2
54. d Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Auto Compact program 5 3 5 9 QC Result analysis Authorized staff should identify and differentiate acceptable unacceptable random errors and trends and or shifts in systematic errors from the statistical data Depending on the users Quality Control Procedures analytical results could be accepted or rejected Changes in QC results can be gradual or abrupt Gradual changes can be caused by contamination and incidental environmental variations Abrupt changes can be caused by change of QC material batch or possible hardware errors If results are continuously out of range due to significant difference between calculated mean and control value but the statistics show precise results with small deviations it should be considered to expand the acceptable assay range with QC Settings If results are incidentally out of range it is advised to perform a daily maintenance and or fill and clean step and then perform another QC sample step before releasing patient results If results are not send to the LIMS QC Results can be exported to MS Excel CSV files for further analysis in lab s own Quality Control data system 5 3 6 History analyse a Analyse results Dilution error Aspect Error vason lt oo fs C Hsry cio fs El Noccellsfplasmafound e C Wi colmo height fo QQoon no Ms O Hays o ERESR Probably gt 140mm 14 O wai Measure error fo C E3 T
55. d Auto Compact has been idle for more than eight hours some reagents may have dropped from the tubes due to gravity Prime all tubing before sampling with PRIME ALL UNITS All priming functions are sequentially performed one time 5 5 1 7 Wash each pipette e Wash each pipette When the pipette belt turns one position the pipette at the rinse position will be rinsed and dried regardless if it was filled or not 5 5 1 8 Wash only sample pipettes e Wash only sample pipettes All pipettes which are currently holding samples are washed and dried ones A warning is shown on the display lt Pipette data will be lost gt NOTE Before executing this function check carefully if there are samples in the pipette belt that need to be measured Any remaining samples will be washed away and will NOT be measured 5 5 1 9 Wash all pipettes e Wash all pipettes All pipettes on the pipette belt are washed and dried ones A warning is shown on the display lt Pipette data will be lost gt NOTE Before executing this function check carefully if there are samples in the pipette belt that need to be measured Any remaining samples will be washed away and will NOT be measured Page 52 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Auto Compact program 5 5 1 10 Fill and clean screen Fill amp Clean Automatic fill and clean function each individual pipette on pipette belt will be filled with cl
56. d tighten the screw cap 4 Liftthe left cover and place the waste container back into the Compact ons Note If you are re cycling waste containers make sure that they are bleached and rinsed thoroughly Page 76 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Rm mechatronics Data safety management 10 DATA SAFETY MANAGEMENT The StaRRsed Auto Compact has its own external PC This means that all collected data is stored on the hard disk of the external computer This means that all raw data and results are kept irrespective of a power failure or if the instrument is un intentionally turned off After the start up procedure the software checks whether there are any ESR s still outstanding If so these will be carried out first After a power failure the sedimentation time 60 or 30 min may be exceeded However the start time is saved and therefore the actual sedimentation time can be checked Important system settings are kept in an internal Flash Eprom inside the instrument In case of corrupted files the program will automatically load and use the backup files 10 1 Power failure If a power failure occurs it is recommended that the StaRRsed Auto Compact is switched OFF by the power switch When the power returns the instrument can be switched ON After the standard start up process the StaRRsed Auto Compact will continue to process the remaining samples StaRRsed Auto Compact Instructions For U
57. e and symbols that draw attention to certain maintenance conditions or QC sample status if applicable Error 5 2 12 Sample screen with keyboard To view the status of a specific pipette click directly on the pipette itself or click the open space in the center of the belt representation A virtual number pad is shown li Sample Ir History a Reagents Maintenance Settings m Service It Gorm d 30 min method STAR SED lompat Auto Compact 2 26 11 Oct 11 14 57 11 Type the number of the requested pipette and press the OK button The following screen is shown Page 22 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN m mechatronics Auto Compact program 5 2 13 Pipette information j Sample 11 History Reagents Maintenance Settings m Service I ile 1 EDTA E 30 min method STAR SED Moo Ww s o o Auto Compact V5 00 The following information is shown Sample ID The sample identification barcode of the sample tube Dilution The dilution rate of this sample as calculated during the aspiration process Time filled The date and time when the sample was aspirated TIME TO GO The number of minutes to wait until the sample will be measured The indicators at the right side show the current status of the selected pipette Pipette filled OK A sample has been aspirated into the pipette without probl
58. e 60 minute method and temperature correction 75 with a correct column height 6 2 5 Reporting range The reporting range in the columns 2 3 and 4 are in millimeters The start of the measure range is at the top of the meniscus down to 140 mm If the detection of cells plasma is over 140 mm then the report will be 2140 StaRRsed Auto Compact Instructions For Use Page 65 Version 1 07 MRN 074 EN mechatronics Reporting 6 2 6 Aspect Hazy The automatic reading of the Westergren sedimentation pipettes is carried out by moving an optical sensor along the pipettes While the sensor is moving a reading is made every 0 25 mm The sensor is reading the absorption of infra red light through the Westergren pipette filled with blood From these readings values at a number of absorption levels are determined All absorption figures are relative to the darkest and lightest reading darkest 100 and the lightest 0 96 absorption respectively By definition the levels are 87 5 Cells plasma separation 75 0 Hazy detection 50 0 Meniscus detection hazy gt 25mm hazy 10 25 mm 25 hazy 10mm _10 dea lt 3mm 3 celis j 100 70 Clear hazy lt 10 mm dynamicaly determined 39 9 out off measure arca to column SS sodimentation 110mm height Graphic showing typical absorption values of a sample Page 66 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechetro
59. e bacterial HEPA filter 6 Remove and disassemble the liquid separator Cleaning 1 Clean all parts with hot water and a brush 2 Use some acid free vaseline on the screw thread of the glass jar 3 Assemble the separator Replacing 1 Replace the top section A little silicon grease on the rim of separator will make the assembling and adjustment easier 2 lf applicable replace the bacterial HEPA filter For Maintenance Level 4 Exchange bacterial HEPA filter QWLV040002 3 Re connect the silicon tube to the tube connector on the top section Lift left cover Lift stainless steel vacuum tube up Insert the liquid separator sliding it over the support shelf Push the liquid separator towards the rear with the sensor connectors in the holes 8 Release the stainless steel vacuum tube 9 Replace the waste container 10 Close left cover NO os Page 112 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN R mechatronics Appendix for StaRRsed Auto Compact 14 APPENDIX FOR STARRSED AUTO COMPACT Appendix section StaRRsed Auto Compact Instructions For Use Page 113 Version 1 07 MRN 074 EN Appendix for StaRRsed Auto Compact Appendix Error list Auto Compact Last updated 01 09 2014 mechatronics DENEN Extra explanation Reason Solution E2 Communication error Board s vex Command x TWSR x E d E3 Measure motor timeout E4 Sample probe not in top
60. e container is not detected This occurs sometimes with the DE IONIZED WATER bottle and is caused by a very low conductivity 2 Addone or two drops of SALINE to the DE IONIZED WATER to increase the conductivity 11 9 Air bubbles After a normal aspiration the Westergren pipette must be free of air bubbles In the following examples different patterns of air bubbles which can appear in the pipettes are shown Air bubbles can affect the sedimentation and are mostly reported as errors and no ESR result is reported Usually bubbles are caused by a leakage at the bottom of the pipette If air bubbles are visible in the pipette check the following 11 9 1 Pipette looks like zebra crossing If this always occurs in the same pipette check the bottom of the pipette for the following F 1 Glass may be chipped e Replace pipette 2 Dirt e g dried blood e Clean the pipette e Check disinfectant flow at the rinse nozzle 3 Perpendicularity and straightness of the bottom face e Replace pipette If this happens randomly or with each pipette check the following 1 Fill nozzle O ring or flat washer 2 Fill nozzle alignment to pipette e Check the nozzle arm is tight on the rear vertical shaft Usually engineer s assistance is required A pipette which looks like zebra crossing gives ESR Error 3 Page 82 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Trouble shooting 11 9 2 Foam in colum
61. e name to select the results of the selected date Press Refresh to refresh the list of available files In the window Sample ID type the sample ID information and press Search Press Options for the following search options e Show today s results e Show today s results from a selected time frame of the day e Show results of a number of past days Default value is set for 7 days e Show results of a specific day e Show results of the range between the first selected date to the next selected date StaHRsed Auto Compact Instructions For Use Page 27 Version 1 07 MRN 074 EN Auto Compact program mechatronics From the selected Sample ID detailed information is shown on this screen Sample ID Aspect code ESR 30 min ESR 60 min ESR 60 min T Corr Date time ESR time min Dilution 96 Temperature Pipet number Error code Page 28 Sample Identification number Shows the aspect code e g Hazy 10 The 30 minute method is used This is the measured 30 minutes value When the 60 minute method is used this is the measured 60 minutes value When the 30 minutes method is used this is the calculated 60 minutes value Temperature correction is used This is the 60 minutes value corrected to 18 Date and time of the measurement of the result Actual duration of the ESR The calculated dilution rate after aspiration of the sample Room temperature at the time of th e measurement of the sample
62. eaning solution During prolonged use of the instrument proteins are building up in the Westergren pipettes which need to be removed using a strong cleaning agent This cycle takes about 90 minutes The Fill amp Clean function is part of the monthly maintenance procedure A warning is shown on the display lt Pipette data will be lost gt Fill and clean Pipette data will be lost Qai Use Fill amp Clean adapter ON By toggling the switch ON the Fill and clean adapter is used By toggling the switch OFF the Fill and clean without adapter is used See chapter Maintenance Fill and clean procedure on page 93 for more information 5 5 1 11 End of day wash procedure e End of day wash All pipettes will be washed once and needle fill nozzle and rinse nozzle wash station are primed StaRRsed Auto Compact Instructions For Use Page 53 Version 1 07 MRN 074 EN Auto Compact program Rm mechatronics 5 5 2 Check sensors 5 o Sample i History k Reagents s Maintenance EE Settings Check sensors QD cera st0p eror QE seth terspersture sensa DFE E onn Temperature Cj Check Dduent flow sensor La D er St sensor Bion C Check Flow sensor Check Separator sensor Iu Gen Check Measure sensor Y Measure sensor Messe l ESP mm Error 1 When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE All functions to check the status of the se
63. eck if the mixer is blocked E69 Position motor error Not on position MIX Page 120 Gripper did not reach the OUT e release position Starting point FILL position Gripper did not reach the MIX position Starting point OUT position Position motor did not reach e the home position or could not detect home sensor Gripper did not reach the IN catch position Starting point MIX position Gripper did not reach the MIX position Starting point FILL position Follow the instructions on the e screen Gripper did not reach the FILL position Starting point MIX or FILL position The mixer motor current exceeded the Maximum mixing current setting during mixing Gripper did not reach the MIX position Starting point IN position mechatronics Position gripper motor is faulty Position gripper motor is blocked Motor driver on rack board is faulty See E61 Check position gripper motor Home sensor Position gripper motor is faulty Position gripper motor is blocked Motor driver on rack board is faulty Check position motor belt See E61 See E61 Check height of the tubes in the rack Check gripper sensor Check rack adapter Check mixer motor settings Mixer motor is blocked Mixer motor is faulty Mixer motor driver on rack board is faulty Check mixer motor belt See E61 StaRRsed Auto Compact Instructions For Use Version 1 07
64. ed mean value and range and the expiry date e The history of QC results is maintained internally Error messages are generated when the QC results are outside the acceptable range e QC samples can be optionally requested by the LIMS and QC results can be send to the LIMS Page 72 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Quality control StaRRsed Control can be used on StaRRsed analysers in EDTA or in Citrate mode Quality Control sampling can be performed at any time during the normal ESR procedure depending on users Quality Control schedule Quality Control scheduling is the responsibility of the user The StaRRsed software does not provide Quality Control scheduling functionality 8 2 5 Quality control procedure StaRRsed Control is provided in ready to use sample tubes and is used in the same manner as patient samples StaRRsed Control is to be used for the Westergren method with dilution only as prescribed by the ICSH review of the measurement of the ESR 2011 and the CLSI Procedures for the ESR Test Approved standard H02 A5 2011 Citrate mode When the StaRRsed analyzer is used in the Citrate mode the StaRRsed Control material must be diluted manually by transferring the necessary amount of material into a pre citrated ESR blood collection tube Immediately after re suspending transfer the necessary amount of material into a pre citrated tube according instructions of the
65. el vacuum tube with use of the lever 3 Pull the liquid separator towards the front of the Compact Note The separator has two sensor connectors at the rear 4 Disconnect the silicon tube from the tube connection on the top section 5 Remove bacterial HEPA filter 6 Remove and disassemble the liquid separator Cleaning 1 Clean all parts with hot water and a brush 2 Use some acid free vaseline on the screw thread of the glass jar 3 Assemble the separator Replacing 1 Replace the top section A little silicon grease on the rim of separator will make the assembling and adjustment easier 2 lf applicable replace the bacterial HEPA filter For Maintenance Level 4 Exchange bacterial HEPA filter QWLV040002 3 Re connect the silicon tube to the tube connector on the top section Lift left cover Lift stainless steel vacuum tube up Insert the liquid separator sliding it over the support shelf Push the liquid separator towards the rear with the sensor connectors in the holes 8 Release the stainless steel vacuum tube 9 Replace the waste container 10 Close left cover NO ose 3 Check sensors Vacuum pressure check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FLOW SENSOR box Flow 0925 0980 1020 Abs 0300 360 0390 Offset 0045 0050 0055 If the flow is not in range there might be a blockage in the vacuum flow line to the flow sensor Fill Stop sensor check Page 100 StaRRsed Auto Compact
66. ems Pipette dirty The sample has been measured and the pipette is marked to be washed when it reaches the rinse station This indicator is also on when a sample could not be aspirated properly Pipette leak Reserved for future use StaHRsed Auto Compact Instructions For Use Page 23 Version 1 07 MRN 074 EN R mechatronics Auto Compact program 5 3 History screen j Sample t History Reagents k Maintenance Settings m Service Select date to show results I Sample ID 30 01 2012 n 27 01 2012 25 01 2012 v SI RN mr a E j gr S 30331602 31 01 2012 08 44 04 2 24 60 EDTA SE 30610002 suouzoi208235 7 Im 24 60 TA 402 30610302 31 01 2001208 23 36 11 124 60 erm ES 30610402 suwyzoi2oe2es 11 24 60 erans 30610502 31 01 200208 41 38 24 e EDTA ll SE 30610702 suonzo1208 2453 2 24 60 EDTA 7 30610502 3woMzo 208 25 43 9 24 60 EDTA D LJ te ED AEN ELS LE LE p 30611002 31 01 2012 08 27 18 1 24 ep EDTAI0 wi 30611602 aromoza 17 a e EDTA 100 3011902 3ifoMz01208 29 2 Jm 24 60 je 1l re 30612102 31 00 201208 30 27 16 24 60 EDTA l Com 30612702 31012012 08 31 16 2 24 60 EDTA jii 1207 30613002 31 01 2012 08 32 05 Ian 24 60 EDTA Pra tesh hears 1397 30613302 aooo 4 ea Jeo o EDA 1405 31006802 aim 10748 12 25 e Im
67. ernnnnne 84 11 10 Quality control trouble shio tihgua icti et et dpt eee 85 StaHRsed Auto Compact Instructions For Use Page 7 Version 1 07 MRN 074 EN mechatronics Contents 12 MAINTENANGE sis iisscsssvcssccevscssccnsvssnesesvesveccnnisnoacnnisnscesdusescesbasntiesbuaenineboavedostucvadnbaa shite 88 p EMO rr m 88 12 1 1 Check or replace sample probe or outer neecdle 89 j ERU 0 90 12 2 1 Check the sensors in service mode en 90 12 2 2 Cleaning liquid separator trina arra nia na sav tua aav aea rara va senses 91 12 3 Level4 maintenance Ree ee ene etie teen e ee se ve EE Ek UE DOE 91 12 8 4 Rinse pump tube replacement AA 91 12 3 2 Saline pump tube replacememt nenen nennen nennen nnen nn nennen nennen 92 12 3 29 Replace bacterial fIIGES 4 2 3 3 4 339 3235 1 23 23 vd 2 xu Fia acd d a a dia 93 12 8 4 Fill nozzle O ring replacement kk 93 12 3 5 Fill ane clean DEG MER aha 93 12 4 Reagents replacement s ssrrrrrrrrrtrtrtttttttttttt1ttttttttttEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE 95 13 WORK INSTRUCTION STARRSED AUTO COMPATCT eene nnne nnns 97 14 APPENDIX FOR STARRSED AUTO COMPATCT 1 eere nnne nnn nnns 113 15 GLOSSARY OF TERMS cccccsesseeeccssseeeeceesseeeceesseeeeeeseeeeueasaeeeneesseseseenseessoeass 125 M2 CC Eai 127 Page
68. es 71 D Daily 70 88 DATA SAFETY MANAGEMENT 77 Display error history 50 56 Display maintenance history 50 57 Display patient results 24 26 27 Display pipette data 24 25 Display rack history 21 24 29 Display rack status 24 29 30 Display reagent history 47 48 Display Sample history 24 26 39 Display sample history QC 39 Document history overview 3 E EDTA mode 125 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Index End of day wash options 59 End of day wash procedure 53 70 End of day wash schedule settings 60 ESR 125 ESR Error 31 64 85 86 ESR Error and Warning code messages 64 74 ESR Statistics screens 24 31 69 Expected value range 72 Explanation of available documentation 9 F Fill and clean procedure 53 93 Fill and clean screen 53 Fill procedure 69 Fill station 21 Fill time out error 80 Fill nozzle O ring replacement 93 Flushing liquids 78 Foam in column e 31 83 G General error procedure 78 GENERAL SAFETY INSTRUCTIONS 17 H Hazy 125 Hazy reports 81 History analyse 24 41 History analyse error 43 History analyse results high dilution 42 History analyse warning 44 History aspect 43 History sample analyse option 45 History sample analyse option day 45 History screen 18 20 24 73 Host 125 INSTALLATION 16 INSTRUMENT DESCRIPTION 11 INTRODUCTION
69. ettings before sampling E42 Mixermotor current settings error Settings loaded from Eeprom Check settings before sampling E43 Motor settings error Settings loaded from Eeprom Check settings before sampling E44 Settings in Eeprom does not match with settings saved to file Check settings before sampling E45 Settings in Eeprom not correct Upload settings before sampling E50 Mixing error Total amount of mixes not the same as setting Check Mix sensor or Rack timer setting T8 or T11 Page 118 Position settings in Eeprom do not match settings saved to file Settings in Eeprom OK and loaded from Eeprom Check positions and save settings Timing settings in Eeprom does not match settings saved to file Settings in Eeprom OK and loaded from Eeprom Check timeouts and save settings Current settings in Eeprom do not match settings saved to file Settings in Eeprom OK and loaded from Eeprom Check current settings and save settings Motor settings in Eeprom do not match settings saved to file Settings in Eeprom OK and loaded from Eeprom Check motor settings and save settings Settings stored in Eeprom are OK and are loaded from Eeprom Check Selected rack setting and save to file Checksum error on settings stored in Eeprom Check Selected rack and save settings Mixer could not do the correct number of mixes within a certain time limit Timing settings T8 or T11 are too low or mixer
70. ficiently Note The narrower bore tube is for the saline pump Page 92 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Rm mechatronics Maintenance 12 3 3 Replace bacterial filters Detailed instructions of this procedure can be found in WI 196 Cleaning liquid separator on page 112 As part of the Cleaning liquid separator procedure the bacterial Hepa filter QWLV040002 is replaced with a new one Exchange bacterial filter QWLV040001 on the waste bottle assembly 12 3 4 Fill nozzle O ring replacement As the fill nozzle O ring QWLV050004 ages it looses its flexibility and air bubbles may occur in the Westergren pipettes the washer needs to be replaced Symptoms for a bad fill nozzle O ring After the aspiration the Westergren pipette has a zebra pattern air blood air blood nicely divided in the column Vacuum stabilisation errors may occur 12 3 5 Fill and clean procedure Note Each pipette on the pipette belt will be filled with cleaning agent after one hour the first pipette is washed and dried Fill and clean takes about 1 1 2 hours to complete Fill and clean with adapter Cleaning agent preparation Auto Compact Fill and clean This cycle takes about 90 minutes 1 Fill the clean adapter VERA119002 with hot de ionized water till the first mark in the adapter 180 ml 2 Add cleaning agent QRR 010905 till the second marker in the adapter 18 ml 3 Place the two cap
71. ge 58 SiaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Rm mechatronics Auto Compact program 5 5 5 1 Maintenance info overview When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE This screen is divided in 6 maintenance level sections For maintenance levels 1 to 4 the status is monitored and flagged if it is overdue Press the button Info to open the work instruction for a specific maintenance level When this maintenance is done press the button Done to log the completed work in the maintenance log file 5 5 6 Close Start End nf day wash procedure or close program Make the selection End of day wash procedure or Close program End of day wash procedure will start to wash all pipettes needle fill nozzle and rinse nozzle wash station The function can be set up for automatic execution in the following screen Close program will only close down the program 5 5 7 End of day wash options End of day wash procedure All pipettes will be washed once needle fill nozzle and rinse nozzle wash station are primed Shutdown settings 4 A No Shutdown Immediately Single We StaHRsed Auto Compact Instructions For Use Page 59 Version 1 07 MRN 074 EN Rm mechatronics Auto Compact program The following settings can be selected for the function e No End of day wash The function is not active e Immediately The function runs immediately after pre
72. gripper maybe blocked mechatronics Configuration file maybe corrupted Configuration file maybe corrupted Configuration file maybe corrupted Configuration file maybe corrupted Configuration file maybe corrupted Possible hardware failure in Eeprom Check rack timing settings T8 amp T11 Check mix sensor distance Mixer is blocked Mixer motor is faulty Mixer motor driver on rack board is faulty StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics E51 Mixer not back in its vertical position Check if mixer is in the vertical position and clear error if OK E54 Endpool full Remove all racks from endpool and then clear error E55 Rack lost in endpool Remove all racks from endpool and then clear error E56 Checksum error motor settings table E57 Checksum error current table E58 Checksum error time table E59 Checksum error position table E60 Mixermotor error Hardware Mixer could not come back in its vertical position after mixing This error will be cleared automatically after removing the racks from the end pool Rack is released from gripper but did not pass the End pool sensor Checksum error on motor settings stored in Eeprom Settings are loaded from file Check Motor settings and save settings Checksum error on current settings stored in Eeprom Settings are loaded from file Check Cur
73. history Rm mechatronics EXE 09 2011 123456700 11201 o ua IE CE MDC ege See a eee CO 7 px TD momen Hacc vc eee n E N we nem Hopes ELO CN fie ES ELI RE cT e c n ds m i4 a o el P REESE NENNEN a D e oS BEE ne ee d mm RECS CR m ncc c ORG Sa ice cm m ERO zc e SES cf San LEEREN a Be dh M c EE MA a Fi t d pc Eier NC Lm A LL EUM See ioi SE Te A nz d cc GS This screen shows the history of the used reagents Select the reagent type on the right side x Loo 14 For external use of the information all the logged reagent data can by exported to EXCEL CSV format by clicking Export to Excel CSV Page 48 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics 5 4 2 New reagent input ES New Reagent Information IR scares SED RINSE SOLUTION 2500 mi Spoelviceistof Sp ll sung Solution de ringage Soluzione di lavaggio Soluci n de lavado Solu o rinse Re mechatronics Rinse solution solution Auto Compact program Select action e Enter new reagent information C Delete current reagent information To continue click Next Input screen for new reagents Make a selection to add new default setting or delete the current information and continue with Next Note Only the Rinse solution input screen is shown in this manual The input screens are the
74. iluter start sensor 400 700 Measure sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK MEASURE SENSOR box Measure sensor MS 40 50 60 Temperature sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK TEMPERATURE SENSOR box Temperature sensor TS Room temperature Diluent flow sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK DILUENT FLOW SENSOR box Press test When test is finished signal Down and signal Up must be green Separator check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK SEPARATOR SENSOR box Separator sensor 200 600 gt 700 6 Final preparation Prepare disinfectant if not already prepared Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 596 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Go to tab MAINTENANCE and perform the End of day wash procedure when Fill amp Clean is used End of day wash is not required 2 Check system for leakage e Inspect the peristaltic pump tubes and connections for leaks e Check that liquid does not run back into the supply bottles after the pumps have stopped 3 Clean and inspect the sample needle e Inspect sample needle condition If necessary replace the sample probe or outer needle See Work Instruction Sample probe or outer needle replacement Page 106 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN
75. ings Operation Air bubble trouble shooting Trouble shooting 1 03 January e Annual update and 2012 publication 1 02 June 2011 Turn off e tis not a problem if the H E van Dijk StaRRsed Auto Compact is on all the time Howewver StaRRsed Auto Compact Instructions For Use Page 3 Version 1 07 MRN 074 EN mechatronics Document history overview 1 01 February Sample screen e Rack pictogram explained H E van Dijk 2011 History screen Preliminary July 2010 All e Manual build from MRN 71 Page 4 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Contents CONTENTS 1 INTRODUGTION A siisiis risici sniinninaaae an anaana aan eieaa iana enaa a aana A Aaaa saN n ERASE AA SEREA anadai 9 1 1 Explanation of available documentaton 9 2 INSTRUMENT DESCRIPTION hine h aaa EPA n RuE P Ex RE USER ni pn E n BEP ERR ERE P ERE M nnna 11 2 1 lechnical specifications eegene 13 2 2 Technical specifications contd ke 15 3 INSTALLATION 16 4 GENERAL SAFETY INSTRUCTIONS 00 cccecceesseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeneeeeeeeeeeeeees 17 LNMEE UE e Le BEE 17 5 AUTO COMPACT PROGRAM acces tic ge unice sup e cece eects 18 5 1 SoftWare ir oom 19 5 2 Sample SCORN EE EE EEN 19 5 2 1 chro T e M 20 5 2 2 eegener Eegeregie tec PbxsEidE 20 5 2 3 EE 20 5 2 4 Pill Station KEE 2
76. ions Qui Show today s results e ai Hour Q From Jj 0 B Show results Make a selection for all of today s results or only today s results between start time and end time 5 3 12 History sample analyse option Search options Sample history options C Show today s results e al L J From Gp Show results e Last Ch day s Day ZJ DD SMnim YY Fal O From Oo Ge _ 2 31 Dec 08 J R X Clean up Sample history OK Cancel Make a selection for 1 Aspecific number of past days 2 A specific date 3 Arange of days from start date to end date StaRRsed Auto Compact Instructions For Use Page 45 Version 1 07 MRN 074 EN mechatronics Auto Compact program 5 3 13 Set start date i Search options Set Time and Date 15 16 iy 22 23 29 5 3 14 Set end date Set Time and Date t WS de Ze b xm en ez Input the End date and time Page 46 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Auto Compact program 5 4 Reagents screen C Sample 4j story Reagents s Maintenance Settings m Service LSA Separator Rinse solution Saline Diluent De ionized Disinfectant water Lot number Lot number Lot number Lot number Lot number fl 123456789 123456769 123456789 123456789 123456789 Expire date pore date Exp
77. ire date Expire date Expire date 11 2011 11 2011 11 2011 11 2011 11 2011 Placed Placed Placed Placed Placed 06 Oct 11 06 Oct 11 06 Oct 11 06 Oct 11 06 Oct 11 EI When there is a sensor alarm an alarm indicator is shown in the tab REAGENTS The alarm status of the bottles and separator are shown in this screen An empty bottle is marked by a flashing red to yellow mark When the bottle status screen is active the bottle audio alarm is switched off Reagent information is shown in the little text boxes To input new reagent information when reagent container is replaced click on the appropriate text box Note When the expire date is exceeded the text box will flash red The software checks the bottle status before starting a new rack If a level alarm is ON it will not process the new rack If an alarm comes ON during a rack it will finish to aspirate that rack 10 samples max Washing dirty pipettes always continues as to avoid that the samples are left in the pipettes Reagents alarm is also set when the expire date of the reagent is exceeded or opened more than three months The message Not allowed now See REAGENTS appears Processing of new samples is stopped A log is available for all reagents and can be accessed by clicking on DISPLAY REAGENT HISTORY on page 48 StaHRsed Auto Compact Instructions For Use Page 47 Version 1 07 MRN 074 EN Auto Compact program 5 4 1 Display reagent
78. irst mark in the adapter 180 ml Add cleaning agent QRR 010905 till the second marker in the adapter 18 ml Place the two caps on the adapter and mix well Put the adapter in the Input pool Select MAINTENANCE PRIME CLEAN button FILL AND CLEAN Pipette data will be lost FD Uuseril amp Cleanadapter ON mM Fees Start Fill and clean procedure 1 2 The adapter will be transported to the needle position 3 4 When all the pipettes are filled the needle goes back to the home position and the Select button OK The needle goes down and the fill and clean process is started adapter is moved to the release position and will be transported into the End pool StaHRsed Auto Compact Instructions For Use Page 111 Version 1 07 MRN 074 EN m _ mechatronics Work instruction StaRRsed Auto Compact R mechatronics Work instruction Number 196 Page 1 of 1 Purpose Cleaning liquid separator Version 2 Safety Bio Hazard area Instrument Compact Revision 002 March 2013 Removing 1 Open the left cover and remove the waste container The liquid separator is now visible 2 Liftthe stainless steel vacuum tube with use of the lever 3 Pull the liquid separator towards the front of the Compact Note The separator has two sensor connectors at the rear 4 Disconnect the silicon tube from the tube connection on the top section 5 Remov
79. m see Foam in column on page 83 ESR errors 96 Increasing ESR errors may indicate the need for maintenance see ESR Error on page 64 Number of samples This can be used to document variations in work load StaHRsed Auto Compact Instructions For Use Page 31 Version 1 07 MRN 074 EN Auto Compact program 5 3 5 QC Results screens mechatronics In this section results and statistics from QC samples are shown in the section Linked QC ID s on page 40 links can be created between QC sample ID s and Lab ID s The results from StaRRsed Control level N and level A are separated on their own tabs Both tabs have the same layout and options Results can be displayed in table format or in graphical format When the StaRRsed Control sample ID is used results are only listed here When Lab ID barcode is used QC results are also listed in Patient results Note This part of the software can only be used in combination with StaRRsed Control as quality control material 5 3 5 1 QC Normal results table 4 OC Statistics and Results 27 01 2012 07 24 01 2012 30 01 2012 07 45 35 03 02 2012 o yazjzo12 EE 25012012 24 01 2012 07 36 3 23 01 2012 07 35 3 03 02 2012 3 DEI SCH 5 SG 9 SES S 5 E117 Uncorrected QC resut E117 Uncorrected QC resul is c E117 Uncorrected QC result is c 13 03 02 2012 20 01 2012 07 36 3 03 02 2012 19 01 2012 10 01 2012 1701 2012
80. mechatronics Work instruction StaRRsed Auto Compact e Clean the outer needle with disinfectant 4 Check tubing from the syringe for trapped air bubbles Check Diluent syringe for trapped air bubbles 6 If trapped air bubbles are found go to tab MAINTENANCE click button PRIME CLEAN ON PAGE 51 and perform the PRIME DILUENT function 7 Wipe outer surface and stainless steel plate below the pipettes with disinfectant e StaRRsed Auto Compact Instructions For Use Page 107 Version 1 07 MRN 074 EN Rm mechetronics Work instruction Number 169 Page 1 of 3 Purpose Cleaning liquid separator Safety Bio Hazard area Instrument Compact Revision Draft October 2001 Prepare disinfectant if not already prepared Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 596 solution This disinfectant is for cleaning of all external parts that are exposed to blood Clean liquid separator 1 Open the left cover and remove the waste container The liquid separator is now visible 2 Liftthe stainless steel vacuum tube with use of the lever 3 Pull the liquid separator towards the front of the Compact Note The separator has two sensor connectors at the rear 4 Disconnect the silicon tube from the tube connection 5 Remove bacterial HEPA filter 6 Open the liquid separator by pulling off the top section 7 Clean the internal parts of the separator with disinfectant
81. motor is not on the MIX position E78 Mixer motor timeout It is possible that the mixer did Check rack timing setting Mixer motor current level did not came back to its home T1 not reach the stop level during vertical position after mixing homing action within a certain time limit Mixer motor is faulty Mixer motor driver on rack board is faulty Check mixer motor belt E80 Position motor error Not Gripper did not reach the IN See E61 on position IN catch position Starting point MIX position E81 Position motor error Not Gripper did not reach the MIX See E61 on position MIX position Starting point IN StaRRsed Auto Compact Instructions For Use Page 121 Version 1 07 MRN 074 EN mechatronics Appendix for StaRRsed Auto Compact NENNEN i E82 Position motor error Not Gripper did not reach the FILL See E61 on position FILL position Starting point MIX position E83 Position motor error Not Gripper did not reach the MIX See E61 on position MIX position Starting point FILL position E84 Position motor error Not Gripper did not reach the FILL See E61 on position FILL position Starting point MIX position E85 Position motor error Not Gripper did not reach the FILL See E61 on position FILL position Starting point last sampled tube E86 Position motor error Not Gripper did not reach the MIX See E61 on position MIX position Starting point FIL
82. n A layer of air bubbles that is concentrated on top of the blood column does not affect the sedimentation process itself The sedimentation develops normally below the bubbles However too many bubbles bring about a shortening of the effective blood column which is a deviation from the Westergren method A layer of bubbles up to 5 mm No message Normal ESR result is reported A layer of bubbles from 5 to 25 mm ESR warning 6 Bubbles on top Results should be reviewed before release A layer of bubbles larger than 25 mm ESR Error 3 Too many borders found No ESR result is given 1 Check that tube connections are not leaking 2 Check the fill nozzle condition e Inspect for any cracks or deep scratches in the base that holds the fill nozzle washer or O ring Check for air in diluter system Check that the sample probe O ring is not leaking 5 Check transparent T piece or Y piece block for cracks uu 11 9 3 One air bubble about 5 mm under meniscus The filling aspiration speed is not critical but should be within certain limits 1 If just one air bubble is found about 5mm below the meniscus the filling speed may be too high 2 The blood column should not exceed the filling height sensor by more than 10mm One air bubble can result in ESR Error 3 StaRRsed Auto Compact Instructions For Use Page 83 Version 1 07 MRN 074 EN mechatronics Trouble shooting 11 9 4 One air bubble rising in
83. n tubes pre filled with citrate solution e The data can be send to your Lab Information System e The used sedimentation pipettes are automatically washed and dried e Minimum sample volume is 1 4 ml for the StaRRsed Auto Compact e The StaRRsed Auto Compact has fully automatic sample loading e The Rack system can work with a variety of hematology analyzer racks with most common EDTA blood sample tubes The system uses rack adapters and is set up for a specific type of rack e Windows based System Software is running on an external computer 1 1 Explanation of available documentation Manuals for the StaRRsed Auto Compact are available on three levels for the operator the supervisor and the service engineer The following manuals are available 1 Instructions for Use IFU Intended for the operator Contains instructions for normal operation safety preventive maintenance and trouble shooting procedures to solve the most common problems Available in several languages StaRRsed Auto Compact Instructions For Use Page 9 Version 1 07 MRN 074 EN RS mechatronics Introduction 2 User Manual UM Intended for the lab supervisor Contains information from the IFU and additional information concerning settings service higher maintenance levels and trouble shooting procedures to solve more complicated problems Only available in English Service Manual SM Intended for trained service engineers Describes maintenance
84. nect the silicon tube to the tube connector on the top section Lift left cover Lift stainless steel vacuum tube up Insert the liquid separator sliding it over the support shelf Push the liquid separator towards the rear with the sensor connectors in the holes 8 Release the stainless steel vacuum tube 9 Replace the waste container 10 Close left cover NO os On waste bottle If used Exchange bacterial filter QWLV040001 on the waste bottle assembly 3 Exchange Rinse and Saline tube assembly New rinse pump tube assembly New saline pump tube assembly ESRIO90902 ESRI090903 E ALINE LER LUE AER New tube replacement 1 Open left cover 2 Pull pump tube slightly downwards and at the same time towards the front of the unit to release the tube out of the pump plate holder 3 Remove the old tube from the peristaltic pump rotor 4 Disconnect the tubing at both ends of the tube connectors Page 104 SiaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Rm mechatronics ONO Work instruction StaRRsed Auto Compact Connect new tubing to both ends of the connectors Place one end of the tube in the pump plate holder Pull the new tube over the peristaltic pump rotor Pull pump tube slightly downwards and at the same time towards the back of the StaRRsed Auto Compact 4 Fill and clean Cleaning agent preparation Auto Compact Fill and clean This cycle takes abou
85. ng Dilution gt 110 all the samples with a dilution rate gt 110 are displayed in the table By selecting Dilution lt 90 all the samples with a dilution rate lt 90 are displayed in the table In the header of the table the names of the columns are shown Double click the header of any column to sort the table by this column in ascending order StaHRsed Auto Compact Instructions For Use Page 41 Version 1 07 MRN 074 EN Auto Compact program 5 3 7 History analyse results high dilution Analyse results Dilution error C Diutton 90 6 piuson 110 30440 38558502 31721102 38575502 42762702 43187202 09310002 08512402 36309802 36950302 37216902 40117602 44261302 DILUTION ERROR Aspect fs Hay cto fe us Qthees O hayas is TET 11 Dec08 15 19 22 1L 0 c08 13 12 19 10 Dec 08 12 47 08 10 Dec08 13 24 53 10 Dec 08 13 08 02 Hi 09 Dec 08 12 10 37 09 Dec 08 14 22 29 09 Dec 08 16 28 42 09 Dec 08 12 06 52 09 Dec 08 16 11 30 EDTAt 10 EDTAILO EDTALIO TEDTAIO Era EDTAIIO EDTALIO T EDTA110 Frau EDTAT10 TEE mechatronics O Et No cellsfplesma found 15 O Wi Column height C EZ ESR Probably gt 140 mm fis C wai Measure error D E3 Too many borders Found ER C wa Bubbles on top ESR Wi Bubbles on top ESR nrBubbles on top ESR i BubblesontopESR 09 Dec 08 16 01 45 09 Dec 06 17 36
86. ng an inquiry 3 times Did not receive ACK from Host after sending inquiry 3 times The Compact could not establish a connection with the HOST server via TCP IP Check the temperature sensor setting Check and or clean the Temperature sensor Check result path setting Check if network or USB devices are used Check communication cable between Host and StaRRsed Auto Compact computer Check serial port settings baud rate etc Check protocol settings Check Host computer Check TCP IP settings Check network cable Check HOST settings No response from Host within See E30 E34 No response from host after sending Sample data record E35 No response from host after sending Sample flag record E36 No ACK NACK received after sending Sample result string E37 NACK received from host after sending Sample result string StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN a certain time limit after 3 attempts No response from Host within a certain time limit after 3 attempts No response from Host within a certain time limit after 3 attempts Did not receive ACK from Host after sending Sample result string 3 times See E30 See E30 See E30 Page 117 Appendix for StaRRsed Auto Compact E40 Position settings error Settings loaded from Eeprom Check settings before sampling E41 Timeout settings error Settings loaded from Eeprom Check s
87. nics Reporting The sedimentation value is the distance in millimeters between the cells plasma level 87 596 absorption and the meniscus If there is no haze the absorption drops quickly to a value below the 75 level If the distance between the 87 5 and the 75 level is less then 3mm the report will state CLEAR If the distance between 87 5 and 75 level is more than 3mm then the report will state HAZY Depending on the length of the hazy area three classes of haziness are reported Length of Reported area class Hazy area area Hazy area gt 25mm 25mm o Hazy gt 25mm Hazy gt 25mm mm Hazy reports are shown when the change from the hazy level to the cell plasma separation level occurs not within a given distance The following code messages are reported in column 5 6 2 6 1 Analyser HAZY code messages This code appears in the sample data record at column 5 The following 4 codes are defined 0 Sample is clear 1 Sample is Hazy 10 2 Sample is Hazy 25 3 Sample is Hazy 25 Results with hazy aspect can be suppressed in the menu Limit error settings StaHRsed Auto Compact Instructions For Use Page 67 Version 1 07 MRN 074 EN Rm mechatronics Operation 7 OPERATION 7 1 Quick start up This section describes a quick start up procedure and a general description of what to do before starting a large batch of samples to run through the sy
88. nsors are grouped under button CHECK SENSORS on page 54 Check Fill stop sensor Click the Check button The green light is shown if the sensor value is in range Check temperature sensor Value must be equal to the actual room temperature near the pipette belt The value can be set in tab SETTINGS Check Diluter start sensor This sensor is only used in EDTA mode If the diluter does not start during the aspiration the status of this sensor must be checked Click the Check button The green light is shown if the sensor value is in range Check Diluent flow sensor This sensor is only used in EDTA mode When activated the LED Down is green and the LED Up is red When the button Test is clicked the LED Up must become green After finishing the test both LED s must be green Check Separator sensor Click the Check button The green light is shown if the sensor value is in range Page 54 SiaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Auto Compact program e Check Flow sensor Click the Check button The green light is shown if the sensor value is in range e Check Measure sensor Click the Check button The green light is shown if the sensor value is in range Press the button MEASURE The pipette currently at the measure position will be measured The results are displayed in graphical form p DERETRESRENSR MES Measure head start position correct EMI c 20 40 60 8
89. nsors in service mode Vacuum pressure check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FLOW SENSOR box Flow 0925 0980 1020 Abs 0300 360 0390 Offset 0045 0050 0055 If the flow is not in range there might be a blockage in the vacuum flow line to the flow sensor Fill Stop sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FILL STOP SENSOR box Fill stop sensor FS 90 140 165 Diluter Start sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select DILUTER START SENSOR box Diluter start sensor 400 700 Measure sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK MEASURE SENSOR box Measure sensor MS 40 50 60 Temperature sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK TEMPERATURE SENSOR box Temperature sensor TS Room temperature Diluent flow sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK DILUENT FLOW SENSOR box Press test When test is finished signal Down and signal Up must be green Separator check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK SEPARATOR SENSOR box Separator sensor 200 600 gt 700 Page 90 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Rm 7 mechatronics Maintenance 12 2 2 Cleaning liquid separator The separator is designed to separate liquid from the air and can handle a lot of blood rinse and other used reagents from the instrument After a period
90. of the setting range e ESR Time e Column height e Dilution e Bubbles on top e Hazy aspect e Temperature Page 64 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Reporting 6 2 4 Limit error settings When an option at Limit error settings is set to YES and this limit error occurs results will be printed send to the LIMS When an option is set to NO and this limit error occurs the fields for 30 min ESH 60 min ESR and the temperature corrected ESR are filled with spaces and thus results are not printed send to the LIMS The error message in the error field column 10 indicates that at least one of the limits ESR time dilution rate column height bubbles on top hazy aspects and temperature has been exceeded Together with the sedimentation time and dilution rate which are still printed at the usual position the operator analyst can see what caused the error and may or may not use the ESR values which are preserved in the error message Description of the error message L_err hhh www ittt ccc L errmeansitis a limit error e hhh is the 30 minutes ESR e www is the 60 minute ESR e ttt is the temperature corrected 60 minute result e ccc is the column height Example of a limit error message e L emt 42 84 75 200 means 42 mm in the 30 minute method and temperature correction 75 with a correct column height e L_err 84 75 200 means 84 mm in th
91. on to the safety precautions specified in this manual e Execute your work according to this manual Read the instructions before operating the instrument Observe all cautionary markings in the manual and on the instrument Keep this manual for future reference e Follow the bio safety procedures when working with blood contaminated parts e Be cautious to prevent stinging during cleaning or replacing the needle assembly e Repair can only be executed by trained and qualified personnel e Wear protective clothing e When the instrument is running it is not allowed to e Open and remove safety covers e Touch moving parts e Itis not allowed to give access to the instrument to a non authorised person at any time e Whenever it is likely that safety protection has been impaired the instrument must be made inoperative and be secured against any unintended operation The matter should then be referred to qualified technicians e Safety protection is likely to be impaired if for example the instrument fails to perform the intended measurements or shows visible damage or unusual smells smoke liquids are flowing out 4 1 Safety warning When there was an incident with the StaRRsed Auto Compact which caused damage to the instrument please notify your superior and your local equipment dealer before you continue using the instrument Example e A collision with a moving object or a person e Something falling on the instrument Liquids s
92. oo many borders found 43 C WS BubblesontopesR 104 136 38582702 11 Dec 08 11 39 48 2 Too many borders found 40078302 j1t0eco8 15 04 10 3 E I T EDTADO Too many borders found 3166502 11 Dec 08 12 32 06 I EDTADO Too many borders found 50247102 11 Dec08 16 10 47 2 I EDTAOO Too many borders Found f 11600002 1t0ec08 10 18 45 23 i EDTAOU2 Too many borders found 11315702 1r0ec08 14 48 58 EDTAO76 11314402 11 Dec 08 14 49 46 e EDTA079 11315102 1 0ec08 14 47 22 S0408602 11 0ec08 14 42 34 11315002 1L Dec08 14 46 36 50367802 01 Dec08 16 20 41 11314702 11 Dec 06 14 36 35 50407202 11 Dec 08 14 41 46 50403902 10 Dec 08 13 32 47 11003802 11 Dec 08 09 09 25 11007002 11 Dec 08 09 17 04 11313602 11 0608 14 50 34 11315502 11 Dec 08 14 48 10 37654402 11 Dec 08 15 02 34 11001502 11 06c 08 09 05 33 11310902 YI Der ff 14 53 64 Prag Too many borders found Etagen EDTADS1 EDTAOS3 Too many borders found Era EDTAD A Pia Too mary borders found EDTAOSS EDTADSS EDTAOBS Etage EDTADES EDTADES FOTANAK sinizieleisisislalelaleiele SIN 2 2 2 8 8 3 8 2 8 22 SVS sl 8 2 2 7 5 z 8 DILUTION ERROR The dilution error detection is a user setting and can be changed in SETTINGS dilution error detection to 0 25 In this example the dilution error detection is set to 10 and limit errors set to YES By selecti
93. or sample identification e Rack transport unit e Automatic mixing of sample tubes before sampling e Needle unit e Diluter module PC with touch screen LCD monitor e Windows based platform e Dedicated instrument software e Optional network connections e USB port Option e External bar code reader which can be connected on the USB port of the Compact Analyzer This bar code reader can be used for reagent handling and for ID input in sample history search AutoCompact LS special model This model uses large bulk containers for reagent supply instead of the 0 5 liter onboard containers This means longer operation time without reagent preparation and no cleaning time This model is delivered with longer level sensors and special reagents cover assembly Page 12 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN R mechetronics Instrument description 2 1 Technical specifications Technical specifications for the StaRRsed Auto Compact StaRRsed AutoCompact instrument models Model name Catalogue number Model StaRRsed AutoCompact VERA109000 StaRRsed AutoCompact VERA109010 LS ESR method Westergren method ESR method Temperature compensation method R W Manley J clin Path 1957 10 354 30 minute method R Rogers Medical Laboratory World 1994 Allowed blood specimen types e For EDTA mode Whole blood with 1 EDTA anticoagulant e For Citrate mode Whole blood
94. ot on position going down Timeout error E12 Dilution error wrong or no diluent flow Check the diluter E13 Fillnozzle not in home position E14 Outer needle motor position error home Appendix for StaRRsed Auto Compact Outer needle did not go down within a certain time limit Fill nozzle did not reach the fill position within a certain time limit Compact was not able to get a stable reading during the vacuum test before aspiration the sample Sample probe was probably jammed when going down and exceeded the maximum current level Sample probe went back to its home position after the error Sample probe did not go down within a certain time limit Diluter malfunction Fill nozzle did not reach the Home position within a certain time limit Outer needle did not reach the home top sensor within a certain time limit StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Outer needle motor is faulty Outer needle motor driver on needle board is faulty Outer needle is blocked Fill nozzle motor is faulty Fill nozzle motor driver on nozzle board is faulty Fill nozzle is blocked Check for leakage on the pipette or fill nozzle Check if outer needle is clogged up with rubber Sample probe maybe bend Sample probe motor is faulty Sample probe motor driver on needle board is faulty Sample probe is blocked Check diluent flow sensor Check tu
95. pecified assay ranges discard the tube and utilize a new tube If difficulties persist contact your supplier for further assistance and or instructions 8 2 8 Temperature correction The assayed values are based on an 60 minutes ESR with dilution and temperature correction Therefore the measured ESR value should be compared with the expected value using temperature correction The calculation of a 30 minute measurement to a 60 minute ESR result with temperature correction influences the QC result See chapter QC Results on page 74 for more information 8 2 4 Usage options StaRRsed Control can be used in two ways 1 With original StaRRsed barcode label The StaRRsed software maintains internal QC history and sends an error message when test results are out of range 2 With user barcode label The user can use his own ID labels hereafter called Lab ID Existing QC procedures and LIMS interface settings can be maintained without any changes The Lab ID is linked within the StaRRsed software to the original StaRRsed Control barcode An external barcode reader can be used to read the 10 character QC barcode labels on the tube or the package insert to create the link The barcode symbology is Code 39 When StaRRsed Control label or a linked user barcode label is used e The StaRRsed software recognises the StaRRsed Control sample by the structure of the barcode which contains the following information Level A or N the expect
96. pilling into the instrument StaHRsed Auto Compact Instructions For Use Page 17 Version 1 07 MRN 074 EN KZ mechatronics Auto Compact program 5 AUTO COMPACT PROGRAM The StaRRsed Auto Compact is controlled via an external computer on which runs the StaRRsed Auto Compact software The software functions are grouped on six tabbed screens The software is controlled by mouse pointer or directly via the touch screen A virtual keyboard is automatically displayed on screen when numerical or alphanumerical input is required Normal operational screens are the SAMPLE and the HISTORY screen The REAGENTS screen is used to check the reagent levels and log reagent replacement To activate priming sequences and cleaning operations the screen MAINTENANCE is used The SETTINGS and SERVICE screens are protected by a password to prevent accidental change of settings The SERVICE menu is used for service and control purposes SAMPLE Screen on page 19 HISTORY screen on page 24 REAGENTS Screen on page 47 MAINTENANCE Screen on page 50 SETTINGS screen is not explained in this manual SERVICE screen is not explained in this manual Page 18 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Rm mechatronics Auto Compact program 5 1 Software version The latest software and manuals for the StaRRsed Auto Compact can be downloaded from our website www rrmechatronics com The following progr
97. pipette 1 Usually this is caused by a wet or dirty fill nozzle e The blood column should not reach right to the base of the pipette There must be a clear air gap of 4 5mm at the bottom of each pipette 2 Insufficient sample volume e Need more blood in the sample tube One air bubble rising can result in ESR Error code 3 11 9 5 Small air bubbles rising in pipette Usually this is caused by a dirty or damaged fill nozzle e Observe the maintenance schedules e Clean the fill nozzle e Check the fill nozzle for damage If necessary replace the fill nozzle Sample tube is leaking on the fill nozzle side e Replace the silicon sample tube Small air bubbles result in ESR Error 3 11 9 6 Random air bubbles in pipette cm 1 Check Diluent flow by priming the diluter system d 2 Insufficient sample volume Random air bubbles result in ESR Error 3 Page 84 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics 11 10 Quality control trouble shooting Trouble shooting Error messages Extra information as E115 QC expired not sampled E116 QC is out of acceptable range E117 Uncorrected QC result is out of acceptable range but corrected result is within range E118 Uncorrected QC result is within acceptable range but corrected result is out of range QC result with ESR error The used StaRRsed Control is out of date no ESR result is given Res
98. position home E5 Duplicated ID E6 Program was not properly shut down Check settings before continuing Page 114 Communication lost after 3 retries between Computer and StaRRsed Auto Compact Measure head motor did not move or motor is blocked Sample probe not back at Home position after sampling a tube Sample rejected Sample already in carousel There is a possibility that changed settings which were not saved to disk are lost Power cable not connected on the communication PCB mounted on the back panel An DC cable not connected Serial cable not connected No power on one of the PCB s Short circuit or fault on one of the PCB s Measure head is not at the Home position Check the Home sensor Motor is faulty Motor driver on drive board is faulty Check sample probe home sensor Sample probe motor is faulty Sample probe motor driver on needle board is faulty Sample probe is blocked Wait until sample is measured Check general settings Check for duplicate ID s Program stopped and computer needed to be reset Computer reset after power failure StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics E7 Outer needle motor position error Timeout piercing E8 Fillnozzle not in fill position E9 Air flow failure E10 Sample probe was jammed Check both needles before sampling E11 Sample probe n
99. r this function is shown The following options are available for this function 1 Select from the list the desired option e No End of day wash The function is not active e Immediately The function runs immediately after pressing OK e Only once The function runs only once at the selected time e Weekdays The function runs only on the working days Mo Fr at the selected time e Daily The function runs on a daily base at the selected time 2 Select the time of the day in hours and minutes for the selected option Pressing OK activates the settings 7 4 2 Turn off sequence e Close the StaRRsed Auto Compact software e Switch the PC and monitor OFF e Switch optional printer OFF e Switch the Compact OFF Page 70 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Quality control 8 QUALITY CONTROL 8 1 Control pipettes The correct function of the hardware and software of the StaRRsed Auto Compact measurement unit should be checked at regular intervals with the aid of Mechatronics Control Pipettes Order nr QTST049000 More information can be found in the Control Pipette User Manual MRN 019 8 2 Monitoring measurement quality with StaRRsed Control StaRRsed Control is an in vitro diagnostic quality control material to monitor the accuracy and precision of Erythrocyte Sedimentation Rate ESR instruments and procedures This instruction is only applicable for StaRRsed Control
100. ram GT ON Wull TUI H This table shows information of the samples in the carousel during the selected ESR process time After measuring the pipette the pipette data is transferred to the sample history files In the header of the table the names of the columns are shown Double click the header of any column to sort the table by this column in ascending order StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Page 25 R mechatronics Auto Compact program 5 3 2 Display Sample history es i Sample E History lir Reagents Maintenance Settings m Service p Select date to show results 30 01 2012 27 01 2012 26 01 2012 25 01 2012 31 01 2012 08 44 04 31 01 2012 08 23 07 31 01 2012 08 23 36 ie Siesegegeg ET TEE 31 01 2012 08 31 01 2012 06 25 41 31 01 2012 08 31 01 2012 08 27 18 31 01 2012 31 01 2012 31 01 2012 08 31701 2012 08 31 01 2012 31 01 2012 08 32 52 31 01 2012 10 27 31 01 2012 10 29 24 31 01 2012 09 47 53 EDTAIO je EDTA EDTA EDTA EDTA T EDTA EDTA EDTA EDTA EDTA EDTA T EDTA EDTA EDTA LL i j E pale seges ss 31 01 2012 10 26 12 _ 91f01j2012 09 36 20 31 01 2012 13 18 26 1 i E S In the window Select date to show results double click on the file name to select the results of the selected date
101. re position When the Compact is running in the NORMAL MODE the instrument uses the standard saved settings For instance the ESR time is set back to 60 minutes or 30 minutes according the used method 5 2 1 Carousel Carousel This is a graphical representation of the Compact carousel When an ESR is required the carousel is moving to the Measure position On the display the belt is also moving accordingly The decimal numbers next to the pipettes are the numbers on the pipette belt When a pipette is filled successfully a red dot marks the filled pipette In case of a failure the pipette is marked with a flashing red dot All the sample information can be found in tab HISTORY 5 2 2 Measure station Measure station This is the position of the measure station where the ESR of the sample is measured 5 2 3 Wash station Wash station Also named Rinse station This is the position where the sample is washed out of the pipette The pipette is clean and dry after this process Page 20 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Auto Compact program 5 2 4 Fill station Fill station This is the position where the pipette is filled with a blood sample 5 2 5 Pipette Pipette This is a graphical representation of the pipette It is generated from the results of the ESR measurement It can be used to locate possible air bubbles 5 2 6 Rack Rack This is a representa
102. rent settings and save settings Checksum error on timing settings stored in Eeprom Settings are loaded from file Check Timeout settings and save settings Checksum error on position settings stored in Eeprom Settings are loaded from file Check Position settings and save settings Could not home mixer motor StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Appendix for StaRRsed Auto Compact Mixer maybe hitting the bottom transport belts Mixer is blocked Mixer motor is faulty Mixer motor driver on rack board is faulty End pool full Check Rack out sensor Rack maybe on its side Check End pool full sensor Check conveyer belt motor Possible hardware failure in Eeprom Possible hardware failure in Eeprom Possible hardware failure in Eeprom Possible hardware failure in Eeprom Check rack timing setting T1 Mixer motor is faulty Mixer motor is blocked Mixer motor driver on rack board is faulty Check mixer motor belt Page 119 Appendix for StaRRsed Auto Compact E61 Position motor error Not on position OUT E62 Position motor error Not on position MIX E63 Position motor error Home sensor E64 Position motor error Not on position IN E65 Position motor error Not on position MIX E66 Gripper error Rack not in gripper E67 Position motor error Not on position FILL E68 Mixing motor current overshoot Ch
103. rogram 5 3 5 2 QC normal results screen extended m OC Statistics and Results QC NORMAL Statistics amp Results Ka Error warning k ESR 30 ESR time e Display n 0 Rests table C Statistics graph j E117 Uncorrected QC resut is d Bubbles on top ESR Batch QCSE42NSO0S j E117 Uncorrected QC resuk is d tll Bubbles on top ESR E117 Uncorrected QC result is d I Bubbles on top ESR lgigigigigigigigisiaigiaigigigigigiaigiaigia After scrolling the general data from the QC results are shown 5 3 5 3 QC normal results graph zi OC Statistics and Results QC NORMAL Statistics amp Results QC results mm Display Cakulated mean mm Man C Res ks table Expected ESR mm e Statistics graph Batch QCOE43NS0S e 9E42N505 350 un D n D n 02 01 2012 07 01 2012 10 01 2012 13 01 2012 16 01 2012 19 01 2012 22 01 2012 25 01 2012 28 01 2012 31 01 2012 bate Calculated mean mm Standard deviation mm Coefficient of variation Number of QC results Page 34 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Auto Compact program Display Statistics graph All QC results from the chosen StaRRsed Control batch are shown in a Levey Jennings chart Shown in the graph e QC results red values of measurements per date e Calculated mean yellow mean value of all QC results of the specific batch e Expected ESR green Assay me
104. s The measured QC results are compared with the Assay mean value and the acceptable range The applicable values for the acceptable range depend on the user setting See chapter QC Settings for more information If applicable the QC result is reported to LIMS using the chosen settings regarding temperature correction display of dilution rate and limit error settings 8 2 6 1 QC Error messages The general ESR errors and warnings are also applied on the QC results see ESR Error and Warning code messages on page 64 When the result is within range no message is shown When the result is out of range an error message is shown in the status line of the Sample screen and the QC icon is blinking on the Sample screen When the sample mode is started again by the operator the following messages appears Last QC result was out of range Continuing could produce incorrect results Do you still want to continue Press Accept to continue sampling without performing a new QC press Cancel to return and take appropriate action Messages when the general setting Temperature Correction is switched ON e E116 QC is out of acceptable range The Sample mode is switched OFF automatically Remaining filled pipettes are processed in the normal manner Messages when the general setting Temperature Correction is switched OFF The software always calculates a temperature corrected result because only temperature corrected results can be
105. s on the adapter and mix well 4 Put the adapter in the Input pool 5 Select MAINTENANCE PRIME CLEAN button FILL AND CLEAN StaRRsed Auto Compact Instructions For Use Page 93 Version 1 07 MRN 074 EN Maintenance Start Fill and clean procedure 1 2 3 4 Select button OK The adapter will be transported to the needle position The needle goes down and the fill and clean process is started When all the pipettes are filled the needle goes back to the home position and the adapter is moved to the release position and will be transported into the End pool Fill and clean without adapter Page 94 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Maintenance The gripper moves to the needle position The needle comes down Fill a container with 150 ml hot de ionized water Add 15 ml cleaning agent QRR 010905 Stir the prepared solution Put the container close to the needle location Push the silicon tube over the sample probe Press CONTINUE The fill and clean process is started ogcougoomrsecowmNmr See also WI 178 Hazy problems on page 109 and WI 195 Cleaning the diluent system Cleaning with Chlorine 12 4 Reagents replacement The StaRRsed Auto Compact can be used with the small onboard reagent containers or with the genuine Mechatronics bulk reagent containers if long level sensors are available After each reagents change the fluid s
106. se Page 77 Version 1 07 MRN 074 EN mechatronics Trouble shooting 11 TROUBLE SHOOTING Occasionally small faults may cause major problems This chapter may help to solve the most common faults and explain why a specific problem occurs A lot of the problems or errors are due to a lack of maintenance Remember that this instrument operates with a considerable amount of whole blood virtually undiluted stores it in a pipette for one hour and then cleans pipettes for re use Therefore it is important to keep to the maintenance schedules It is recommended that trained service personnel checks and applies service to the instrument at least once a year Errors which are not explained in this section can usually not be solved by the operator Refer to the Service manual for more information available only in English The error numbers are displayed in the PC software 11 1 General error procedure Whenever an error occurs follow the instructions given in the error message on screen If no instructions are given follow this general procedure Clear the error by pressing button CLEAR ERROR When the error is not cleared or the error occurs again Close the StaRRsed Auto Compact PC software Switch the Compact OFF Switch the Compact ON Start the StaRRsed Auto Compact PC software When the error occurs again switch OFF all units and call for service 9 gr d com gt 11 2 Flushing liquids After each sample aspiration the
107. ssing the button OK e Only once The function runs only once at the selected time e Weekdays The function runs only on working days monday till friday at the selected time e Daily The function runs on a daily base at the selected time 5 5 8 End of day wash schedule settings End of day wash procedure All pipettes will be washed once needle fill nozzle and rinse nozzle wash station are primed Shutdown settings Select the time of the day in hours and minutes for automatic start of this function 5 6 Settings screen The SETTINGS screen is for specially trained supervisors and engineers and outside the scope of the Instructions For Use 5 7 Service screen The SERVICE screen is for specially trained engineers and outside the scope of the Instruction For Use Page 60 SiaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics Reporting 6 REPORTING The StaRRsed Auto Compact is able to handle different types of protocols The selection is made in SERVICE SERIAL OUTPUT SETTING 6 1 Protocols A protocol is a set of rules governing the communication and the transfer of data between machines as in a computer system It is also a formal set of rules and procedures to be followed during a request for information before data is transferred between machines and computer Systems The following protocols can be selected for data transfer to the Laboratory data processor computer No
108. stem 7 1 1 Check list Run this checklist before each large batch of samples 1 Waste container if applicable should be empty 2 Check the liquid levels 7 1 2 Power up sequence Switch ON procedure e Switch ON the Compact e Switch ON the PC and monitor e Wait until Windows is ready for use e Start the Compact software 7 1 3 Priming the fluid system Select MAINTENANCE gt PRIME CLEAN on page 51 and perform all prime sequences manually Check fluid flow through the applicable tubing repeat a step if fluid flow is not correct 1 PRIME RINSE SOLUTION activates the Rinse pump RINSE SOLUTION must flow through the pipette 2 PRIME SALINE activates the SALINE pump Liquid must flush through the needle assembly 3 PRIME DILUENT activates the diluter prime cycle Diluter system must be filled with diluent and free of air bubbles e Diluter prime cycle is executed once In order to fully prime the system it will be necessary to perform this step several times One cycle is 5 strokes of the Diluter 4 PRIME DE IONIZED WATER activates the fill nozzle water valve DE IONIZED WATER must flow through the tube connected to the fill nozzle cap 5 PRIME DISINFECTANT activates the disinfectant valve Disinfectant must flow through the small tube connected to the pipette wash station When the StaRRsed Auto Compact has been idle for more than eight hours some reagents may have dropped from the tubes due to gra
109. t 90 minutes 1 Fill the clean adapter VERA119002 with hot de ionized water till the first mark in the adapter 180 ml Add cleaning agent QRR 010905 till the second marker in the adapter 18 ml Place the two caps on the adapter and mix well Put the adapter in the Input pool Select MAINTENANCE PRIME CLEAN button FILL AND CLEAN Pipette data will be lost SP Use Fill amp Clean adapter ON Start Fill and clean procedure 1 2 The adapter will be transported to the needle position 3 4 When all the pipettes are filled the needle goes back to the home position and the Select button OK The needle goes down and the fill and clean process is started adapter is moved to the release position and will be transported into the End pool StaRRsed Auto Compact Instructions For Use Page 105 Version 1 07 MRN 074 EN mechatronics Work instruction StaRRsed Auto Compact 5 Sensor check Vacuum pressure check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FLOW SENSOR box Flow 0925 0980 1020 Abs 0300 360 0390 Offset 0045 0050 0055 If the flow is not in range there might be a blockage in the vacuum flow line to the flow sensor Fill Stop sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FILL STOP SENSOR box Fillstop sensor FS 90 140 165 Diluter Start sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select DILUTER START SENSOR box D
110. tes are housed in the carousel Each is of precision bore glass After each cycle the pipette is cleaned automatically with low foam detergent followed by a drying cycle The fill line is back flushed using saline solution The temperature is corrected to the standard value of 18 and ESR s may be read after one hour or 30 minutes A foretell one hour result is presented in the 30 minute mode The StaRRsed Auto Compact can be interfaced bidirectionally with Laboratory Information Management Systems LIMS through a variety of interface protocols Results of the test are expressed in millimeters This data together with the patient ID number is sent to the Laboratory Information System along with the sedimentation time used 60 or 30 minutes the temperature and the dilution ratio i li n I l ET E e UM ee Get Iw Mk ALLL StaRRsed Auto Compact Instructions For Use Page 11 Version 1 07 MRN 074 EN mechatronics Instrument description The StaRRsed Auto Compact analyzer consists of the following units StaRRsed Compact analyzer e ESR measuring instrument with a belt holding 84 precision s bore glass Westergren pipettes e Automated aspiration of the sample tube e Automated dilution of EDTA blood sample with citrate e Automated measurement of ESR after 30 or 60 minutes e Automated cleaning and drying of pipettes StaRRsed Rack e Add on unit for sampling and rack handling e Barcode reader f
111. tion of a rack in process Empty positions indicate that no sample tube was detected at that position The combinations of the pictograms have the following meaning IM uiam Barcode could not be read read failure 0000000544 Wu OK l Barcode was read correctly but ESR is not required for this sample 0000000941 WU LORS ll 0000000940 INI uoc Kel ESR was measured successfully ESR is required and waiting to be done 000000936 uo Hell ESR was measured but with fill errors After processing the rack the information of the rack is transferred to the DISPLAY RACK HISTORY on page 29 screen 5 2 7 Sample mode button Sample mode button This is the button to start or stop the run mode of the instrument 5 2 8 Version information Version information Shows the version information of the software 5 2 9 Manual input sample ID Manual input sample ID This window can be used for manual input of a barcode from a sample tube StaHRsed Auto Compact Instructions For Use Page 21 Version 1 07 MRN 074 EN Re mechatronics Auto Compact program 5 2 10 Sample information Sample information After measurement the results of the sample are shown in this window This window is refreshed after every new result of a sample 5 2 11 Status Status Information about the current status of the instrument is shown here such as the selected mode EDTA or Citrate selected method 60 or 30 minut
112. top sensor checked 12 Oct 11 11 03 45 Measure sensor 12 Oct 11 11 03 42 Flow sensor checked 11 Oct 11 09 03 30 Fyll amp Rensa avbrutet 11 Oct 11 09 01 10 Fyll amp Rensa genomf rt 11 Oct 11 08 58 55 Fyll amp Rensa avslutat 11 Oct 11 08 53 54 Fall amp Rensa genomf rt 10 Oct 11 09 43 53 Measure sensor checked 03 Oct 11 08 18 57 Temperatursensorn kontrollerad 03 Oct 11 08 18 41 Temperatursensom kontroller ad 03 Oct 11 08 18 41 Sp dningsfl dessensorn kontrollerad 03 Oct 11 08 18 40 Separatorsensorn kontrollerad 03 Oct 11 08 16 38 Mitningssensorn kontrolleradi Auto Compact program m Service BB When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE All performed maintenance functions are logged automatically This log can be saved e g to a memory stick by clicking button Save As StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Page 57 Rm mechatronics Auto Compact program 5 5 5 Maintenance info When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE This screen is divided in 6 maintenance level sections For maintenance levels 1 to 4 the status is monitored and flagged if it is overdue Press the button Info to open the work instruction for a specific maintenance level When this maintenance is done press the button Done to log the completed work in the maintenance log file Pa
113. uble shooting 74 85 124 Quick start up 68 R Rack 21 Random air bubbles in pipette 84 Reagents 79 Reagents alarm 79 Reagents replacement 95 Reagents screen 18 20 47 Replace bacterial filters 93 Replacing the waste container 76 Report 30 Minute mode 63 Report 60 Minute mode 62 REPORTING 61 Reporting range 65 Result Printout 62 Rinse pump tube replacement 91 S Safety warning 17 Saline pump tube replacement 92 Sample information 22 Sample mode button 21 Sample screen 18 19 Sample screen with keyboard 22 SAMPLE VOLUME 9 Separator error 79 Service screen 60 Set end date 46 Set start date 46 Settings screen 60 Small air bubbles rising in pipette 84 Software version 19 Status 22 T Technical specifications 13 Technical specifications contd 15 Temperature correction 72 125 TROUBLE SHOOTING 78 Turn off e 70 Turn off sequence 70 U Unidirectional 126 Usage options 72 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN R mechetronics V Version information e 21 W Wash all pipettes 52 Wash each pipette 52 Wash only sample pipettes 52 Wash station 20 WASTE DISPOSAL 76 Weekly 90 WI 126 WORK INSTRUCTION STARRSED AUTO COMPACT 97 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Index Page 129
114. uld result in filling errors E24 Diluter Start sensor out The Diluter Start sensor has of range Check clean this reached a critical level nsor n S dd Continuing could result in filling errors The Measure sensor has reached a critical level E25 Measure sensor out of range Check clean this nsor TU ES Continuing could result in wrong ESR results E26 Diluent Flow sensor out The EDTA Flow sensor has of range Check clean this reached a critical level sensor Continuing could result in Page 116 The Fill sensor has reached a Check and or clean the Fill sensor Check and or clean the Diluter Start sensor Check and or clean the Measure sensor Check and or clean the EDTA Flow sensor StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics E27 Temperature sensor out of range Check Settings E29 Result path not found Switched to default D Check Result Path setting E30 No ACK NACK received from host after sending inquiry E31 NACK received from host after sending inquiry E32 LIMS Connection timeout Host not found Appendix for StaRRsed Auto Compact tng eras EH The measured room temperature has reached a critical level Continuing could result in wrong ESR results Selected result path is not valid Software is using the default setting No response from Host within a certain time limit after sendi
115. ult is out of range the applicable values for the acceptable range depend on the user setting E116 is shown in the status line of the Sample screen and the QC icon is blinking on the Sample screen ESR Result is given ESR Result is given Temperature correction not activated ESR Result is given Temperature correction not activated no ESR Result is given StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Check expire date Use a new batch of StaRRsed Control Try new QC sample tube normal samples will be finished Check acceptable range in QC settings If results are continuously out of range but the statistics show identical stable results it should be considered to expand the acceptable assay range with QC Settings If this error persists check clean instrument Consider QC Sample as correct The mean value is assayed with temperature correction Check temperature correction setting Consider QC Sample as not correct Try new QC sample tube normal samples will be finished Check acceptable range in QC settings If this error persists check clean instrument Check temperature correction setting Check general ESR data see ESR Error on page 64 Check sample tube volume Try new QC sample tube Page 85 mechatronics Trouble shooting QC result with ESR warning ESR Result is given Check general ESR data general ESR Warnings on page 64
116. unit T UI I 2 i Unfasten the screw which prevent the outer needle to drop out of the assembly Undo the sample probe Pull the outer needle complete with sample probe together out the needle assembly Mark each tube for easier reconnecting to the correct nipple Disconnect the tubes from the outer needle Needle exchange O UE deca I cs Install new sample probe ESRIO50909 together with a new outer needle VERAO59009 Slide the new sample probe into the new outer needle Make sure the Sample probe has a new O ring QWLV050003 Install new sample probe ESRIO50909 together with the new outer needle Put the sample probe in the outer needle Replace the needles onto the needle assembly StaRRsed Auto Compact Instructions For Use Page 89 Version 1 07 MRN 074 EN mechatronics Maintenance 7 Tighten the sample probe Do not over tighten the sample probe in the T piece Y piece or it Will crack or strip the threading inside the block 8 Replace the correct tubes on the outer needle 9 Fasten the outer needle bolt Do not over tighten the screw 10 Replace the cover on the Rack unit 12 2 Weekly The purpose of the weekly maintenance is to carry out the daily maintenance and additionally check the optical sensor of the measure head and the vacuum pressure Detailed instructions of this procedure can be found in the Work Instruction Weekly maintenance on page 99 12 2 1 Check the se
117. up position E116 118 Quality Control Errors Page 124 Could not start the position motor because the outer needle or sample probe is not its home position top mechatronics Check outer needle home sensor Check sample probe home sensor Faulty Outer needle motor Faulty Sample probe motor Check if needles are blocked Faulty motor drivers on the needle board See section Quality control trouble shooting on page 85 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN mechatronics 15 GLOSSARY OF TERMS B 15 1 1 1 1 Bidirectional communication means that there is two way communication from the StaRRsed Auto Compact to the HOST sample requests and results and from the HOST to the StaRRsed Auto Compact confirmation or denial of sample requests C 15 1 1 1 2 Citrate mode is used for pre diluted samples collected in tubes with sodium citrate anticoagulant diluent The samples are not diluted on the StaRRsed Auto Compact during aspiration The concentration of sodium citrate within the diluent solution in the tube should be 3 296 This is not to be confused with the required dilution rate of blood and diluent For example in a citrate tube with a total draw volume of 1 6 ml 2 5 volumes the amount of pre filled diluent must be 0 32 ml 1 volume If this information is not provided by the tube manufacturer it should be checked by the customer E
118. used on Mechatronics ESR StaRRsed instruments StaRRsed Control is available in Abnormal range Level A Normal range Level N The software can produce statistical data for further analysis for e Defining control limits accept or reject patient results e Error detecting systematic or random errors e Evaluation of QC results 8 2 1 Limitations StaRRsed Control is to be used for Erythrocyte Sedimentation Rate testing only and shall not be used to control any other hematology procedure StaRRsed Control shall not be used as a standard StaRRsed Control should not be used past the expiration date Mechatronics as supplier of the StaRRsed Control shall not be liable for any claimed damages arising from other than intended usage StaRRsed Auto Compact Instructions For Use Page 71 Version 1 07 MRN 074 EN Rm mechatronics Quality control 8 2 2 Expected value range StaRRsed Control is assayed for the StaRRsed ESR analyzers The assayed mean values and expected ranges are derived from multiple analyses at different sites and on multiple instruments The values provided on the package insert and encoded in the tubes barcode are specific for this lot of product The lab should establish its own acceptable ranges Whenever the Controls fail to perform consistently within the acceptable ranges patient results should be considered invalid Contact your StaRRsed instrument provider for assistance If results vary outside the s
119. vity Prime all tubing before sampling with PRIME ALL UNITS All priming functions are sequentially performed one time Page 68 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN 7 2 Fill procedure Fill the sample rack with the sample tubes Observe that the barcodes are visible through the opening in the rack Place the rack in a rack adapter Set the Rack adapter in the rack loader with the barcodes facing the rack grabber Select the tab SAMPLE and press the button Sample mode The Rack is transported to the rack grabber the rack grabber picks up the Rack adapter and moves to the barcode reader position to scan the first barcode label The rack is then mixed and after that moved to the needle position to be aspirated If the barcode labels fail to read check if the barcode is facing the correct direction Note BE SURE THAT THE COMPACT IS SET TO THE CORRECT MODE i e EDTA or CITRATE 7 2 1 Liquid levels Liquid containers and levels must be checked frequently If the small onboard bottles are used wash and keep the bottles clean to avoid bacterial growth The StaRRsed Auto Compact has liquid level sensors When the level sensor alarm appears replace reagent as soon as possible 7 3 Checks during operation e Perform regularly visual checks for air bubbles in the sample pipettes see Air bubbles on page 82 e Check regularly the ESR statistics in the software for any increase in ESR errors haziness
120. wn here StaHRsed Auto Compact Instructions For Use Page 39 Version 1 07 MRN 074 EN Rm mechatronics Auto Compact program 5 3 5 8 Linked QC ID s zh OC Statistics and Results Use this screen to link the StaRRsed Control sample ID with a Lab ID or to check which links are active 1 StaRRsed Control sample ID Enter the lot number or scan the barcode from the original StaRRsed Control tube label If the original label is already covered by the Lab ID label find the lot number and barcode on the package insert 2 Lab ID Enter the patient number or scan the barcode from the label that the lab is using to identify the sample 3 Click button Link ID s to add the linked ID s to the list The Date linked will be added automatically 4 Attach the Lab ID label on the StaRRsed Control sample tube so that the original barcode is completely covered to ensure that only the Lab ID barcode can be scanned by the StaRRsed Auto Compact If the StaRRsed Control sample ID is not correct or the expiry date is exceeded a message will be shown and the ID s are not added to the list To remove a link that will no longer be used select the link in the table and click on REMOVE LINK Depending on the optional setting AUTOMATICALLY REMOVE LINKED QC ID AFTER RESULT SETTINGS QC SETTINGS the links can be removed automatically when a usable ESR result has been reported for this particular Lab ID Page 40 StaRRse
121. y Statistics graph All QC results from the chosen StaRRsed Control batch are shown in a Levey Jennings chart Shown in the graph e QC results red values of measurements per date e Calculated mean yellow mean value of all QC results of the specific batch e Expected ESR green Assay mean value of chosen StaRRsed Control Shown as value e Calculated mean mean value of all QC results of the specific batch e Standard deviation the average deviation of all QC results compared with the expected ESR e Coefficient of variation ratio of the standard deviation to the expected ESR expressed in a percentage e Number of QC results This graph gives a first indication of the measuring stability of the StaRRsed Auto Compact Further analysis and identification of systematic errors have to be performed in the user s Quality Control System CLOSE Return to History Screen Page 38 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN Rm mechetronics Auto Compact program 14 12 2012 13 12 2012 12 12 2012 11 12 2012 This screen shows all patient results that have been measured after the selected QC result and up to the following QC result The results are presented in the layout of the DISPLAY SAMPLE HISTORY on page 26 screen Depending on the frequency of QC samples related patient results may span over multiple days and are listed per date All general ESR data and errors of QC samples are sho
122. ystem must be primed 1 Select MAINTENANCE gt PRIME CLEAN on page 51 2 Perform the applicable prime step to fill the relevant tubes with reagent and remove air For AutoCompact LS To replace the bulk reagent containers Remove level sensors and spacers from the empty container Remove empty container Place new container Remove the container screw caps and pull the necks of the bottle packs out of the cardboard box EON StaRRsed Auto Compact Instructions For Use Page 95 Version 1 07 MRN 074 EN mechatronics Maintenance 5 Install the level sensors and spacers according the following pictures Make sure to place the appropriate level sensors in the containers by matching the color codes on the tube and on the container The sensors and the reagents have the following numbers and color codes Connector Reagent number Color code RINSE SOLUTION Number 34 Green SALINE Number 35 Yellow DILUENT Number 36 Grey DE IONIZED WATER Number 37 Blue DISINFECTANT Number 38 White NOTE Wrongly placed pickup tubes may cause incorrect results or instrument malfunction After each reagents change the fluid system must be primed 1 Select MAINTENANCE gt PRIME CLEAN on page 51 2 Perform the applicable prime step to fill the relevant tubes with reagent and remove air Page 96 StaRRsed Auto Compact Instructions For Use Version 1 07 MRN 074 EN R mechatronics Work
123. zzle holder Assemble fill nozzle Push the plastic top part down against the Spring pressure 1 1 Connect the silicon tube to the fill nozzle 2 Putthe fill nozzle into the holder Turn the plastic top part until you hear 4 Push the fill nozzle upwards and turn of feel a click the holder to the left 2 Turn the plastic top part clokwise for 1 5 turns 2 Clean Liquid Separator and exchange filters Removing 1 2 3 4 5 6 Cleaning 1 2 3 Open the left cover and remove the waste container The liquid separator is now visible Lift the stainless steel vacuum tube with use of the lever Pull the liquid separator towards the front of the Compact Note The separator has two sensor connectors at the rear Disconnect the silicon tube from the tube connection on the top section Remove bacterial HEPA filter Remove and disassemble the liquid separator Clean all parts with hot water and a brush Use some acid free vaseline on the screw thread of the glass jar Assemble the separator StaHRsed Auto Compact Instructions For Use Page 103 Version 1 07 MRN 074 EN Rm mechatronics Work instruction StaRRsed Auto Compact Replacing 1 Replace the top section A little silicon grease on the rim of separator will make the assembling and adjustment easier 2 If applicable replace the bacterial HEPA filter For Maintenance Level 4 Exchange bacterial HEPA filter QWLV040002 3 Re con

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